GMP:Blog

 

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26.10.2021 | LOGFILE Feature 40/2021

Non-Sterile Drug Products: Microbial Risks

Non-Sterile Drug Products: Microbial Risks

6 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.


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19.10.2021 | LOGFILE Feature 39/2021

Packaging Material Testing: The Role of Your Suppliers

Packaging Material Testing: The Role of Your Suppliers

7 min. reading time | by André Deister, Sabine Mendel

 

The supplier of the packaging materials plays an important role when pharmaceutical packaging materials undergo testing. Because of the numerous materials involved, the complexity of the manufacturing process and the extremely specific test parameters, many of the packaging material tests are carried out at the supplier.


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12.10.2021 | LOGFILE Feature 38/2021

What’s new for ICH Q9 and ICH Q12?

What’s new for ICH Q9 and ICH Q12?

7 min. reading time | by Sabine Paris, PhD

 

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.


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05.10.2021 | LOGFILE Feature 37/2021

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?

Defect Evaluation Lists and Defect Pattern Libraries Create them yourself – but how?

7 min. reading time | by Felix Tobias Kern, PhD, and Fritz Röder

 

Defect evaluation lists and defect pattern libraries are popular GMP documents that have been used for more than 45 years. They serve as a rationale for the quality assessment of individual batches and set quality standards for the manufacture and testing of pharmaceutical products.


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28.09.2021 | LOGFILE Feature 36/2021

Basis of Cleaning Validation: Setting of PDE Limits

Basis of Cleaning Validation: Setting of PDE Limits

11 min. reading time | by Cornelia Wawretschek, Jens Hrach, PhD


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21.09.2021 | LOGFILE Feature 35/2021

Process Development as the Basis for Process Validation

Process Development as the Basis for Process Validation

7 min. reading time |

 

A GMP compliant and successful process validation is only possible when a 'robust' 1 pharmaceutical development of the medicinal product has been performed, regardless of which development methods are applied.


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14.09.2021 | LOGFILE Feature 34/2021

Test interval for integrity testing of HEPA filters in a laminar flow above an injection moulding machine

Test interval for integrity testing of HEPA filters in a laminar flow above an injection moulding machine

12 min. reading time | by Harald Flechl

 

Question:

We operate a laminar flow above an injection moulding machine in a cleanroom, GMP Grade C (ISO 8 in operation, ISO 7/at rest). The laminar flow achieves ISO class 5 within the cleanroom area.


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07.09.2021 | LOGFILE Feature 33/2021

IT Service Providers: Service Level Agreement

IT Service Providers: Service Level Agreement

8 min. reading time | by Markus Roemer, Siegfried Schmitt, PhD

 

The written contract on the outsourced activities can take the form of an internal service agreement or an external service agreement. In both cases, it is used to describe.

 


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31.08.2021 | LOGFILE Feature 32/2021

Stability Studies During the Authorisation Phase of Medicinal Products

Stability Studies During the Authorisation Phase of Medicinal Products

7 min. reading time | by Heike Meichsner, Olaf Mundszinger, PhD, Susanne Schweizer

 

The registration batches correspond as nearly as possible to the later commercial batches in the marketing phase with regard to the equipment, starting materials and manufacturing processes used.


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24.08.2021 | LOGFILE Feature 31/2021

Remote, Distance, Offsite or Virtual Audits?

Remote, Distance, Offsite or Virtual Audits?

12 min. reading time | by Thomas Peither


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03.08.2021 | LOGFILE Feature 30/2021

Planning, Construction and Commissioning of an Isolator

Planning, Construction and Commissioning of an Isolator

8 min. reading time | by Richard Denk

 

Isolator applications and design

Isolators are used in the handling of toxic and highly potent substances and in the production of sterile products.


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27.07.2021 | LOGFILE Feature 29/2021

Practical implementation of the PQS

Practical implementation of the PQS

9 min. reading time | by Stephanie Blum

 

In addition to the preceding general statements on the PQS, Chapter 1 of the EU GMP Guidelines contains specific information on GMP for medicinal products and quality control.


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20.07.2021 | LOGFILE Feature 28/2021

GMP Inspections: Organisation of the Front and Back Office

GMP Inspections: Organisation of the Front and Back Office

9 min. reading time | by Thomas Peither

 

The inspection is carried out in the front office and prepared in the back office. The preparation room is used to train and instruct staff.


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14.07.2021 | LOGFILE Feature 27/2021

Qualification Master Plan: Regulatory Requirements

Qualification Master Plan: Regulatory Requirements

11 min. reading time | by Thomas Peither

 

A definition of the term “qualification master plan (QMP)“ is not to be found in the GMP guidelines, only the term “validation master plan (VMP)”, which serves as a parent document.


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06.07.2021 | LOGFILE Feature 26/2021

Alternative Approach to Risk Assessment of Computerised Systems

Alternative Approach to Risk Assessment of Computerised Systems

9 min. reading time | by Dennis Sandkühler

 

On the basis of the process-related requirements set out in the specifications, ISPE GAMP® 5 provides for a process risk analysis to identify risks relating to patient safety, product quality, data integrity and compliance requirements.


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29.06.2021 | LOGFILE Feature 25/2021

Frequent Deficiencies in GMP Inspections – Here: Insufficient Maintenance of Rooms

Frequent Deficiencies in GMP Inspections –  Here: Insufficient Maintenance of Rooms

9 min. reading time | by Lea Joos

 

The deficiency

During a tour of the production area, it was discovered at several points that the rooms were not sufficiently maintained:


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22.06.2021 | LOGFILE Feature 24/2021

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

7 min. reading time | by Stephanie Blum

 

With this e-learning course you can get familiar with the topic of Good Distribution Practice (GDP)!


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15.06.2021 | LOGFILE Feature 23/2021

Requirements for Balances Used in Pharmaceutical Production

Requirements for Balances Used in Pharmaceutical Production

10 min. reading time | by Christian Gausepohl

 

When selecting balances, technical aspects such as resolution, precision and weighing range must be taken into account, as must special design features.


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08.06.2021 | LOGFILE Feature 22/2021

Design Qualification for Premises and Air Handling Units

Design Qualification for Premises and Air Handling Units

7 min. reading time | by Harald Flechl

 

The design qualification process may vary depending on the project and the client's requirements and may be carried out in two or three design phases.


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01.06.2021 | LOGFILE Feature 21/2021

Contract Manufacturing: Technology Transfer Phases

Contract Manufacturing: Technology Transfer Phases

10 min. reading time | by Chistian Gausepohl

 

The transfer of a product to a contract manufacturer can be divided into different phases.


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25.05.2021 | LOGFILE Feature 20/2021

Survey of qualified persons on remote certification

Survey of qualified persons on remote certification

15 min. reading time | by Ulrich Kissel and David Cockburn

 

Social distancing posed an interesting question for the Qualified Person (QP) in the early days of the COVID-19 pandemic:


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18.05.2021 | LOGFILE Feature 19/2021

Importance of Supplier Qualification Status

Importance of Supplier Qualification Status

7 min. reading time | by Christian Gausepohl

 

Most companies have established different categories (qualification status) for the suppliers of starting materials and packaging materials they use.


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11.05.2021 | LOGFILE Feature 18/2021

Innovations in Pharmaceutical Manufacturing

Innovations in Pharmaceutical Manufacturing

8 min. reading time | by Thomas Peither

 

Were you able to follow the PDA Annual Meeting of the Parenteral Drug Association this year? Or were you like many others who spent the whole day with web meetings and have no time or mood for more online conferences?


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04.05.2021 | LOGFILE Feature 17/2021

European Safety Referral: Short and Crisp

European Safety Referral: Short and Crisp

4 min. reading time | by Michael Hiob and Sabine Paris,PhD

 

A referral is a procedure used to resolve concerns over the safety, efficacy or quality of a medicinal product (or a class of medicines). In a referral, the EMA is requested to conduct a scientific assessment of the products in question on behalf of the European Union (EU).


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27.04.2021 | LOGFILE Feature 18/2021

The GMP:Blog is online!

The GMP:Blog is online!

The time has come, the curtain goes up! Now your brand-new online journal is launched.
Let the newly designed GMP:Blog support you in the work with GMP.


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20.04.2021 | LOGFILE Feature 15/2021

Specifications for packaging materials

Specifications for packaging materials

5 min. reading time | by Roland Kleissendorf

 

A correctly formulated packaging material specification provides a comprehensive description of the packaging material and serves as a guideline for the respective packaging materials supplier.


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13.04.2021 | LOGFILE Feature 13/2021

Agency Expectations on PDE Reports

Agency Expectations on PDE Reports

8 min. reading time | by Sabine Paris

 

In 2015, with the revision of Chapters 3 and 5 and Annex 15 of the EU GMP Guide and with the publication of the EMA PDE Guideline a paradigm shift took place in establishing limit values for the validation of cleaning processes.


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06.04.2021 | LOGFILE Feature 13/2021

GMP Risk Analysis in Qualification

GMP Risk Analysis in Qualification

18 min. reading time

 

Today’s feature focuses on GMP risk analysis. It is an excerpt from the E-Learning GMP:READY – GMP for Engineers. GMP:READY provides knowledge for the planning, qualification and maintenance of the pharmaceutical equipment and facilities.


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30.03.2021 | LOGFILE Feature 12/2021

Data Integrity in the Quality Control Laboratory

Data Integrity in the Quality Control Laboratory

5 min. reading time | by Markus Veit

 

Introduction

This chapter deals with the practical aspects of implementing the European requirements for data integrity.


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23.03.2021 | LOGFILE Feature 11/2021

Insufficient traceability of the batch documentation

Insufficient traceability of the batch documentation

12 min. reading time | by Dr. Sabine Paris

 

The deficiency

Time specifications for the start of production (preparation from 8:30) and for the end of production (15:30) were entered in the batch documentation.


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16.03.2021 | LOGFILE Feature 10/2021

Rouging When Stainless Steel Corrodes

Rouging When Stainless Steel Corrodes

12 min. reading time | by Herbert Bendlin

 

What is rouging?


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09.03.2021 | LOGFILE Feature 09/2021

The GMP Regulations Report 2020

The GMP Regulations Report 2020

11 min. reading time | by Sabine Paris

 

For all of us, the year 2020 turned out quite differently than we had ever imagined. People everywhere are struggling with new challenges. The GMP world was not spared, either. To name just a few: inspections were carried out remotely to a large extent and many regulations remained in draft form for the time being.


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02.03.2021 | LOGFILE Feature 08/2021

3 Systems for Cleanroom Walls

3 Systems for Cleanroom Walls

8 min. reading time | by Harald Flechl

 

Over the past several years, wall and ceiling systems have become the established state of the art in finishing technology. The numerous manufacturers of such systems also offer solutions that are suitable for fire zones and large, high rooms – such as warehouse storage rooms.


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23.02.2021 | LOGFILE Feature 07/2021

EMA Guideline on the Quality of Water for Pharmaceutical Use

EMA Guideline on the Quality of Water for Pharmaceutical Use

12 min. reading time | by Tim Sandle

 

Controlling water quality in pharmaceutical facilities requires an assessment of chemical and microbial risks. Of foremost concern is water-for-injections (WFI). This grade of water can be prepared using either reverse osmosis or by distillation.


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16.02.2021 | LOGFILE Feature 06/2021

Insight at Second Glance - The Human Error and its Root Causes

Insight at Second Glance - The Human Error and its Root Causes

10 min. reading time | by Doris Borchert and Christian Gausepohl

 

To err is human - and is only too willingly used as the most probable cause for deviations of all kinds. It is also temptingly easy to look for the cause of error in individual (mis)behaviour.


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09.02.2021 | LOGFILE Feature 05/2021

2 Approaches for Implementing ICH Q3D

2 Approaches for Implementing ICH Q3D

10 min. reading time | by Paulino Alonso

 

ICH Q3D 'Guideline for Elemental Impurities' applies to finished drug products. It provides the basis for an adequate control of elemental impurities (generally referred as 'heavy metals' or 'metallic impurities'). The publication of this guideline has brought several consequences:


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02.02.2021 | LOGFILE Feature 04/2021

TOP 15 Countdown: "Question of the Week"

TOP 15 Countdown: "Question of the Week"

10 min. reading time

 

Every week we publish GMP related questions which you might have asked yourself before. You get short and precise answers, links and working material to the corresponding chapters in the GMP Compliance Adviser.


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26.01.2021 | LOGFILE Feature 03/2021

26th PTS GMP Conference – Current Topics Presented Virtually

26th PTS GMP Conference – Current Topics Presented Virtually

12 min. reading time | by Doris Borchert

 

There is a first time for everything - in this case for the digital format of the GMP Conference, which PTS Training Service organised for the 26th time on 1 December 2020.


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19.01.2021 | LOGFILE Feature 02/2021

Containment in Perfection: The Isolator Technology

Containment in Perfection: The Isolator Technology

10 min. reading time | by Richard Denk

 

The literal meaning of containment is “holding together” or in its common sense “limiting expansion”. In the active ingredient, pharmaceutical and biopharmaceutical industries it is understood to mean the enclosure of a production process or a dangerous location.


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04.01.2021 | LOGFILE Feature 01/2021

Digitalised Crisis Response for Pharmaceutical Production

Digitalised Crisis Response for Pharmaceutical Production

9 min. reading time | by Felix Michler

 

The demands on manufacturers in the pharmaceutical industry are constantly increasing. Global competition and the international production and supply of raw materials and active ingredients increase the complexity of supply chains.


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15.12.2020 | LOGFILE Feature 48/2020

Online packaging line controls

Online packaging line controls

6 min. reading time | by Vera Werner


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08.12.2020 | LOGFILE Feature 47/2020

Brief spots on autumn conferences

Brief spots on autumn conferences

5 min. reading time | by Thomas Peither

 

In September 2020 the series of virtual autumn conferences of PDA and ISPE started. We were present and pick out some excellent sessions with this LOGFILE feature.


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01.12.2020 | LOGFILE Feature 46/2020

Certification of products manufactured outside the EU

Certification of products manufactured outside the EU

6 min. reading time | by Rainer Gnibl

 

Excerpt from the GMP Compliance Adviser Chapter 14.J and the GMP Series e-book EU-Compliant Batch Release of Medicinal Products


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24.11.2020 | LOGFILE Feature 45/2020

Insufficient cleaning validation

Insufficient cleaning validation

5 min. reading time | by Lea Joos

 

The deficiency

During the cleaning validation, the PDE values of the active ingredients were determined in order to implement the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.


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17.11.2020 | LOGFILE Feature 44/2020

Can the author of a GMP document also act as its reviewer?

Can the author of a GMP document also act as its reviewer?

3 min. reading time

 

Is there a normative source for the fact that the reviewer of a document cannot be the same person who prepared it?


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10.11.2020 | LOGFILE Feature 43/2020

Criticality classifications of deviations

Criticality classifications of deviations

5 min. reading time | by Felix Tobias Kern and Liwa Schneider

 

The correct and consistent classification of deviations into the categories Minor, Major and Critical is a constant challenge for pharmaceutical manufacturers. A systematic specification is a prerequisite for the elimination of subjective components of the classifying QA function and the QPs.


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03.11.2020 | LOGFILE Feature 42/2020

What is the point of "heating" medicinal products to 15–25 °C?

What is the point of "heating" medicinal products to 15–25 °C?

6 min. reading time | by Christoph Frick

 

There is no legal, ecological or pharmaceutical reason why a preparation should be heated from 12 °C (the outside temperature), for example, to a constant temperature of 20 °C (i.e. the mean of 15–25 °C) and stored at this temperature.


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27.10.2020 | LOGFILE Feature 41/2020

Thoughts on the transport of pharmaceuticals from a claims handling perspective

Thoughts on the transport of pharmaceuticals from a claims handling perspective

13 min. reading time | by Axel Radke

 

Research, development and production of a medicinal product are usually in the hands of the marketing authorization holder (MAH). These processes are therefore subject to the direct supervision and control of the MAH.


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20.10.2020 | LOGFILE Feature 40/2020

Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?

Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?

8 min. reading time | by Hedley Rees

 

The Foundational Role of Pharma R&D in the Supply Chain

Not for the first time, pharma supply-chains have become the subject of global debate among key stakeholders, but for the wrong reasons.


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13.10.2020 | LOGFILE Feature 39/2020

Regulatory compliance - issue identification

Regulatory compliance - issue identification

5 min. reading time | by Mark Tucker

 

Issue identification is the most critical part of the process and relies on a team of people with high operational and GMP knowledge. All operational and quality areas should be represented and assessed.


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06.10.2020 | LOGFILE Feature 38/2020

Optimum GMP training concept: modular and inclusive e-learning

Optimum GMP training concept: modular and inclusive e-learning

8 min. reading time | by Christine Oechslein

 

In Part I, Paragraph 2.11 of the EU GMP Guidelines, it is required that "approved training programmes should be available" in GMP-liable establishments.


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29.09.2020 | LOGFILE Feature 37/2020

ICH Update Quality Initiatives

ICH Update Quality Initiatives

7 min. reading time | ​by Sabine Paris

 

For almost 30 years now, the PDA/FDA Joint Regulatory Conference has been taking place once a year. From 14 to 16 September 2020 it was a virtual-only event for the first time. The title of the conference was "The Future Is Now: Effective Quality Management and Robust Manufacturing".


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22.09.2020 | LOGFILE Feature 36/2020

Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

5 min. reading time | by Crystal Booth

 

When selecting the number of sites to be sampled, the author recommends utilizing established guidelines. For example, ISO 14644-1:2015 contains a table used to establish the number of nonviable (total) particulate samples required based on the size of the room to be monitored.


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16.09.2020 | LOGFILE Feature 35/2020

Sliding doors in cleanrooms - "no go" or "best practice"?

Sliding doors in cleanrooms - "no go" or "best practice"?

5 min. reading time | by Harald Flechl / Doris Borchert (editorial editing)

 

In cleanrooms, it is necessary to create a clear demarcation to adjacent, less clean areas. Since the beginning of clean room technology, airlocks have established themselves as an effective means of separating rooms.


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08.09.2020 | LOGFILE Feature 34/2020

Inadequate handling of deviations: the cause "human error"

Inadequate handling of deviations: the cause "human error"

5 min. reading time | by Lea Joos

 

The deficiency

In the case of the deviation inspected, it was found that the batch number, which had to be manually transferred to the product before production started, was not correctly transferred to the product. The cause was found to be a "human error" in the manual transfer of the batch number during the root cause analysis.


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25.08.2020 | LOGFILE Feature 32/2020

How do you organize GMP knowledge and relevant news in your organization?

How do you organize GMP knowledge and relevant news in your organization?

8 min. reading time | by Thomas Peither


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04.08.2020 | LOGFILE Feature 31/2020

Two different pairs of boots: GMP for APIs and GMP for medicinal products

Two different pairs of boots: GMP for APIs and GMP for medicinal products

5 min. reading time | by Rainer Gnibl

 

Some essential differences between EU GMP Guide Part I (GMP for medicinal products) and Part II (GMP for APIs) are:


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28.07.2020 | LOGFILE Feature 30/2020

Filter integrity test

Filter integrity test

7 min. reading time | by Ruven Brandes

 

The integrity of the filter must be checked before and after use. This is a requirement of the EU GMP Guide1 and of the Ph. Eur. 2 The FDA3 also requires the integrity check, focussing on performance after the filter has been used.


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21.07.2020 | LOGFILE Feature 29/2020

Substance-based medical devices

Substance-based medical devices

5 min. reading time | by Felix Tobias Kern

 

The differentiation between medical devices and medicinal products is a constant challenge for pharmaceutical manufacturers. Does my product meet the definition of a medical device according to the EU Medical Device Directive (MDD) or the definition of a medicinal product according to EU-Directive 2001/83 for medicinal products?


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07.07.2020 | LOGFILE Feature 27/2020

Work instructions, records and documentation

Work instructions, records and documentation

5 min. reading time | by Christine Oechslein

 

Any action related to medicinal products must be traceable, because the life and health of humans and animals are at stake.


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30.06.2020 | LOGFILE Feature 26/2020

Hygienic design of pharmaceutical manufacturing processes - example: tablet press

Hygienic design of pharmaceutical manufacturing processes - example: tablet press

5 min. reading time | by Richard Denk

 

When designing facilities there are numerous aspects to consider. These include not only the regulatory and normative requirements but also the functionality and cost effectiveness as well as the principles of hygienic design.


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23.06.2020 | LOGFILE Feature 25/2020

GMP:READY: GMP for Engineers

GMP:READY: GMP for Engineers

5 min. reading time


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09.06.2020 | LOGFILE Feature 23/2020

FMD alerts in 2020 – where we are a year into legislation

FMD alerts in 2020 – where we are a year into legislation

9 min. reading time | by Grant Courtney


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02.06.2020 | LOGFILE Feature 22/2020

Environmental Risk Assessment: ERA Reports

Environmental Risk Assessment: ERA Reports

8 min. reading time

 

1 Introduction: environmental risk evaluation


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26.05.2020 | LOGFILE Feature 21/2020

Purpose and content of a management review

Purpose and content of a management review

5 min. reading time | by Stephanie Blum

 

A management review is carried out on a regular basis to check the suitability and effectiveness of the pharmaceutical quality system (PQS). It is one of the most effective PQS tools available.


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19.05.2020 | LOGFILE Feature 20/2020

Challenges lurking in manufacturing

Challenges lurking in manufacturing

8 min. reading time | by Dr. Sabine Paris

 

Experts:            GMP inspector Lea Joos, Christian Gausepohl, PhD, QP and Head of Quality Unit


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12.05.2020 | LOGFILE Feature 19/2020

12 FREQUENTLY ASKED QUESTIONS on SOPs

12 FREQUENTLY ASKED QUESTIONS on SOPs

7 min. reading time | by Brian Matye, Jeanne Moldenhauer, Susan Schniepp

 

Question: How often should I review my SOPs?


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05.05.2020 | LOGFILE Feature 18/2020

Nothing ventured, nothing gained

Nothing ventured, nothing gained
28.04.2020 | LOGFILE Feature 17/2020

Disruptive technologies in the production of pharmaceuticals

Disruptive technologies in the production of pharmaceuticals

8 min. reading time | by Nadja Schaubhut

 

A GMP-DIALOGUE of the GMP Conference, the GMP-BERATER Tage, in October 2019 revolved around the topic "Disruptive technologies in the production of pharmaceuticals". The participants asked questions about the topic, which the two experts answered in an exciting discussion.


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21.04.2020 | LOGFILE Feature 16/2020

Batch Designation: Handwritten or Electronic?

Batch Designation: Handwritten or Electronic?

5 min. reading time | by Doris Borchert

 

In our company, every step of the production process is documented on the batch processing record, which is printed out on paper beforehand. Prior to this, all batches used were entered in the record by hand. This often resulted in an unclear spelling.


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15.04.2020 | LOGFILE Feature 15/2020

Acceptance testing or qualification?

Acceptance testing or qualification?

7 min. reading time | by Harald Flechl

 

Buildings for pharmaceutical production and the therein integrated infrastructure systems have in common that they have to be planned, realised and operated individually and according to the specific case. This individual character results in an increased risk of faults, which must be recognised and rectified in a timely manner so that they do not endanger the quality of the produced medicinal products.


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08.04.2020 | LOGFILE Feature 14/2020

The QP should decide or "lessons learned"

The QP should decide or "lessons learned"

7 min. reading time | by Sabine Rabus

 

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "The QP should decide or lessons learned". The participants brought along concrete questions, the experts gave clear answers. A lively exchange developed, during which the participants also reported in detail on their experiences. We have summarised the most important results for you in this protocol.


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01.04.2020 | LOGFILE Feature 13/2020

GMP training courses in the online offline tension field

GMP training courses in the online offline tension field

7 min. reading time | by Sabine Paris

 

Are you already training online or still offline? What do the employees, the management, the works council and other stakeholders want? How can this be controlled and GMP-compliant? How can blended learning be implemented?


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24.03.2020 | LOGFILE Feature 12/2020

The power of the comma Or: What do print data have to do with drug safety?

The power of the comma Or: What do print data have to do with drug safety?

5 min. reading time | by Doris Borchert

 

Would you have known? Around 90% of all product recalls by pharmaceutical companies are due to errors in printed packaging materials. It is not the quality of the drug per se that calls patient safety into question, but incorrect or faulty information on the packaging.


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18.03.2020 | LOGFILE Feature 11/2020

Questions about manufacturing technology

Questions about manufacturing technology

7 min. reading time | by Doris Borchert

 

At our GMP conference, the GMP-BERATER Tage in October 2019 the GMP-DIALOGUE on the topic "Technology for the manufacture of medicinal products" took place. Questions on the topic were asked by participants and answered by GMP inspector Rainer Gnibl, PhD and technology-expert Ruven Brandes in a lively discussion.


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10.03.2020 | LOGFILE Feature 10/2020

Trust is good, calibration is better!

Trust is good, calibration is better!

11 minutes reading time | by Hansjörg Gutmann, Markus Kopf, Markus Salemink, Dr. Christian Sander

 

Numbers play a key role in the manufacture of medicinal products. From the receipt of the raw materials to the final release of the finished product, results (actual values) are repeatedly compared with specifications (target values) to decide whether the quality meets the requirements. This applies equally to measured values in the manufacturing process and to analytical results in the laboratory.


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04.03.2020 | LOGFILE Feature 09/2020

The GMP Regulations Report 2019

The GMP Regulations Report 2019

15 min. reading time | by Sabine Rabus

 

EMA: Update of Q&A on EU/US MRA, December 2019


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26.02.2020 | LOGFILE Feature 08/2020

7 Basic GMP Questions and Answers

7 Basic GMP Questions and Answers

7 min. reading time | by Dr. Sabine Paris

 

A GMP DIALOGUE of the GMP Conference, the GMP BERATER Tage, in October 2019 was entitled "Basic GMP questions and answers". Here, the questions could be asked to which the participants always wanted to have an answer. The two experts provided answers in the course of a lively discussion.


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18.02.2020 | LOGFILE Feature 07/2020

MHRA: Feedback from GMP inspections

MHRA: Feedback from GMP inspections

15 min. reading time | by Tim Sandle

 

To assist pharmaceutical manufacturers and distributors to understand the areas where good manufacturing practice (GMP) inspectors have found compliance problems during GMP inspections in the UK and overseas, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) GMP Inspectorate has issued data, during October 2019, relating to common deficiencies from previous GMP inspections conducted during 2018 [1].


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11.02.2020 | LOGFILE Feature 06/2020

Packaging material testing

Packaging material testing

5 min. reading time | by André Deister, Sabine Mendel

 

Pharmaceutical packaging materials have a variety of functions. The main purpose of primary packaging materials, for example, is to protect the medicinal product against the physical effects of light, air and moisture. Secondary packaging materials provide information on the amount, dosage type and application of the packaged medicinal product.


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04.02.2020 | LOGFILE Feature 05/2020

TOP 15 Countdown: “Question of the Week”

TOP 15 Countdown: “Question of the Week”

10 min. reading time

 

As a LOGFILE subscriber you are already familiar with our "Question of the week". 


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28.01.2020 | LOGFILE Feature 04/2020

Microbiological monitoring in non-sterile areas

Microbiological monitoring in non-sterile areas

7 min. reading time | ​by Doris Borchert

 

At our GMP Conference, the “GMP-BERATER Tage“, in October 2019 we presented a GMP dialogue on "Microbiological Monitoring in non-sterile areas". Questions on the topic were asked by participants and answered by GMP inspector Franz Schönfeld, PhD and microbiologist Frank Mertens, PhD in a lively discussion.


read more ...
22.01.2020 | LOGFILE Feature 03/2020

Selection and procurement of cleanroom construction components

Selection and procurement of cleanroom construction components

5 min. reading time | ​by André Deister, Sabine Mendel

 

Selection and procurement


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14.01.2020 | LOGFILE Feature 02/2020

GDP inspections: How to avoid defects

GDP inspections: How to avoid defects

7 min. reading time | by Lea Joos and Doris Borchert

 

Mrs. Joos, you put in your new chapter "GDP inspections: Frequent deficiencies and how to avoid them" the 10 most common deficiencies in the qualification of logistics service providers. In your opinion, where are the biggest deficits?


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07.01.2020 | LOGFILE Feature 01/2020

Your question – our answer: Environmental Monitoring

Your question – our answer: Environmental Monitoring

7 min. reading time

 

"We have an active pharmaceutical ingredient (ICH Q7) in our GMP warehouse which may be stored up to max. 40°C according to the stability data available. This is the suspension of a UV filter. Now the existing monitoring system is to be replaced.


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10.12.2019 | LOGFILE Feature 46/2019

Failure Management in a GMP Regulated Environment

Failure Management in a GMP Regulated Environment

5 min. reading time | by Martin Mayer

 

An excerpt from the GMP Series e-book Failure Management in a GMP Regulated Environment


read more ...
03.12.2019 | LOGFILE Feature 45/2019

Ventilation units, or the invisible energy in the clean room

Ventilation units, or the invisible energy in the clean room

9 min. reading time | by Doris Borchert

 

Ventilation units are the heart of cleanrooms. They enable the air to circulate in the same way as the heart enables the blood to do so in the human body.


read more ...
26.11.2019 | LOGFILE Feature 44/2019

PDA/FDA Joint Regulatory Conference 2019

PDA/FDA Joint Regulatory Conference 2019

6 min. reading time | by Thomas Peither

 

The PDA/FDA Joint Regulatory Conference in September in Washington, DC, was once again an important meeting place for the pharmaceutical industry this year. Topics ranged from regulatory updates, quality aspects, compliance challenges, new technologies for manufacturing, laboratory and quality assurance to control strategies, facility life cycles, inspection strategies and audit effectiveness.


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19.11.2019 | LOGFILE Feature 43/2019

Transfer of analytical procedures to the contract laboratory

Transfer of analytical procedures to the contract laboratory

4 min. reading time | by Frank Böttcher

 

An excerpt from the e-book Managing Contract Manufacturers and Testing Labs and the online knowledge portal GMP Compliance Adviser


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12.11.2019 | LOGFILE Feature 42/2019

In 8 steps to self-learning FMEA

In 8 steps to self-learning FMEA

6 minutes reading time | by Felix Tobias Kern

 

The legislation's demand on the pharmaceutical industry for an integrated risk approach (e.g. according to ICH Q9) implies major challenges in terms of effort and costs.


read more ...
05.11.2019 | LOGFILE Feature 41/2019

New Toxicological Assessment Services of GMP Publishing

New Toxicological Assessment Services of GMP Publishing

10 minutes reading time | by Sabine Paris

 

Pharmaceutical manufacturers regularly have to implement new regulatory requirements. The EMA, for example, requires the setting of health based exposure limits (PDE values) for all medicinal products manufactured in shared facilities.


read more ...
29.10.2019 | LOGFILE Feature 40/2019

Batch release process steps

Batch release process steps

6 min. reading time | by Rainer Gnibl

 

The actual batch release procedure for finished products can be subdivided into three steps. These build up on each other and should be carried out chronologically.


read more ...
22.10.2019 | LOGFILE Feature 39/2019

Sliding doors in clean rooms – "no go" or "best practice"?

Sliding doors in clean rooms – "no go" or "best practice"?

7 min. reading time | by Harald Flechl and Dr Doris Borchert (editorial editing)

 

In clean rooms, it is necessary to create a clear demarcation to adjacent, less clean areas. Since the beginning of clean room technology, airlocks have established themselves as an effective means of separating rooms.


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15.10.2019 | LOGFILE Feature 38/2019

Is there a legal requirement for the document language of GMP-relevant documents?

Is there a legal requirement for the document language of GMP-relevant documents?

4 min. reading time | by Sabine Rabus

 

In our company it is planned to write all documents in English. However, many employees do not speak English. Is there a rule that says that the documents must be "readable and understandable" for employees?


read more ...
08.10.2019 | LOGFILE Feature 37/2019

EDQM inspections and trends of deficiencies relating to API facilities

EDQM inspections and trends of deficiencies relating to API facilities

10 min. reading time | by Tim Sandle

 

In recent years, there has been an increase in international drug inspections to assure that good manufacturing practice (GMP) is being appropriately applied no matter where a bulk pharmaceutical chemical or active pharmaceutical ingredient (API) is made. With the regulation and inspection of API manufacturers falling under agencies operating in the European Economic Area, there has been little (until now) trend data relating to facility inspections.


read more ...
01.10.2019 | LOGFILE Feature 36/2019

Data integrity in the quality control laboratory

Data integrity in the quality control laboratory

5 min. reading time | by Markus Veit


read more ...
24.09.2019 | LOGFILE Feature 35/2019

Your E-Learning Trial Version

Your E-Learning Trial Version

2 min. reading time


read more ...
17.09.2019 | LOGFILE Feature 34/2019

Passive transport packaging

Passive transport packaging

5 min. reading time | by Christoph Frick and Nicola Spiggelkötter

 

Passive shipping containers are characterized by the insulation material used and the cooling media. Both components then determine the running time, which can be between 24 and 120 hours. Simple cooling boxes are made of polystyrene, high-end versions feature vacuum panels.


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10.09.2019 | LOGFILE Feature 33/2019

Administration and control of substances

Administration and control of substances

3 min. reading time | by Markus Limberger

 

An important aspect of dealing with substances in a laboratory is the administration and control of the substances. It is important that the substances are only used as intended and before their shelf life expires.


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03.09.2019 | LOGFILE Feature 32/2019

GDP - DIN SPEC 91323: Uniform testing standards for vehicles used for the transport of pharmaceuticals

GDP - DIN SPEC 91323: Uniform testing standards for vehicles used for the transport of pharmaceuticals

12 min. reading time | by Sabine Rabus

 

The transport of pharmaceuticals is subject to strict requirements. This reality has long since arrived in logistics. Transparency, reliability and compliance with rules are therefore part of the daily business of a pharmaceutical logistics company.


read more ...
27.08.2019 | LOGFILE Feature 31/2019

Zone concept and clean room classes

Zone concept and clean room classes

6 min. reading time | by Christine Oechslein

 

If somebody kept their shoes in a china cupboard or prepared a cream cake in the bathroom (directly beside the hairbrush and razor), most people would find it unhygienic. We are used to our living room and other rooms being used for particular activities.


read more ...
06.08.2019 | LOGFILE Feature 30/2019

PDA Annual Meeting 2019 – Part 2

PDA Annual Meeting 2019 – Part 2

10 min. reading time | by Thomas Peither

 

Robotics in Future's Factory


read more ...
30.07.2019 | LOGFILE Feature 29/2019

Optimum GMP training concept: modular and inclusive e-learning

Optimum GMP training concept: modular and inclusive e-learning

8 min. reading time | by Christine Oechslein

 

In Part I, Paragraph 2.11 of the EU GMP Guidelines, it is required that "approved training programmes should be available" in GMP-liable establishments.


read more ...
23.07.2019 | LOGFILE Feature 28/2019

PDA Annual Meeting 2019 – Part 1

PDA Annual Meeting 2019 – Part 1

10 min. reading time | by Thomas Peither

 

What an exceptional conference! From June 25th-26th, 2019, the PDA Europe Annual Meeting in Amsterdam was again a meeting that demonstrated the current view on important topics in the pharmaceutical business. The first part of the conference summary covers the plenary session in the morning of the first conference day.


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16.07.2019 | LOGFILE Feature 27/2019

Pharmacopoeias in the context of quality control

Pharmacopoeias in the context of quality control

4 min. reading time | by Markus Veit

 

Pharmacopoeias play an important role in quality control. They define important standards and framework conditions for tests; they contain requirements for reagents and reference materials as well as specifications for active substances (APIs), excipients, packaging materials and medicinal products. In addition, pharmacopoeias also contain descriptions of all relevant test methods.


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09.07.2019 | LOGFILE Feature 26/2019

GMP and GDP Activities in Storage Areas

GMP and GDP Activities in Storage Areas

4 min. reading time | by Christian Gausepohl and Jürgen Ortlepp

 

Incoming goods and dispatch

"Receiving and dispatch bays should protect materials and products from the weather.


read more ...
02.07.2019 | LOGFILE Feature 25/2019

Management of GMP Projects and New Factory Buildings

Management of GMP Projects and New Factory Buildings

8 min. reading time | by Sabine Paris

 

At the GMP BERATER Days in October 2018, the GMP Dialogue on "Management of GMP Projects and New Factory Buildings" took place. Questions about the topic were asked by the participants and answered by the experts Dr Helmut Bender, Boehringer Ingelheim, and GMP inspector Dr Daniel Müller and in a lively discussion.


read more ...
18.06.2019 | LOGFILE Feature 23/2019

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

5 min. reading time

 

With this e-learning course you can get familiar with the topic of Good Distribution Practice (GDP)! The aim is to explain the GDP-Regulation principles in a quick and sufficient way.


read more ...
11.06.2019 | LOGFILE Feature 22/2019

Outsourcing: How to Assign a Contract Laboratory

Outsourcing: How to Assign a Contract Laboratory

5 min. reading time | by Frank Boettcher

 

Apart from the statutory requirements that must be observed, commercial aspects and corporate policy also have a role to play when selecting a contract laboratory.


read more ...
04.06.2019 | LOGFILE Feature 21/2019

The aims and basic principles of the PQS

The aims and basic principles of the PQS

4 min. reading time | by Stephanie Blum

 

Every patient who is ill and takes a medicinal product hopes it is effective and heals the illness or at least alleviates the symptoms.


read more ...
28.05.2019 | LOGFILE Feature 20/2019

ICH Q12 - Set menu or buffet?

ICH Q12 - Set menu or buffet?

6 min. reading time | by Sabine Paris

 

The European Annual Conference of the International Society of Pharmaceutical Engineering (ISPE) attracted over 700 participants to Dublin from 1st to 3rd April 2019. The main topic was “Drive and Leverage Innovation for Pharma”.


read more ...
21.05.2019 | LOGFILE Feature 19/2019

GMP training courses in the online offline tension field

GMP training courses in the online offline tension field

5 min. reading time | by Sabine Paris

 

Are you already training online or still offline? What do the employees, the management, the works council and other stakeholders want? How can this be controlled and GMP-compliant? How can blended learning be implemented?


read more ...
14.05.2019 | LOGFILE Feature 18/2019

The power of the comma, or: What do print data have to do with drug safety?

The power of the comma, or: What do print data have to do with drug safety?

6 min. reading time | by Doris Borchert

 

Would you have known? Around 90% of all product recalls by pharmaceutical companies are due to errors in printed packaging materials. It is not the quality of the drug itself that calls into question patient safety, but incorrect or erroneous information on the packaging. A comma on our bank statements can bring tears to our eyes or a smile on our lips.


read more ...
07.05.2019 | LOGFILE Feature 17/2019

Drive and Leverage Innovation for Pharma

Drive and Leverage Innovation for Pharma

7 min. reading time | by Sabine Paris

 

The European Annual Conference of the International Society of Pharmaceutical Engineering (ISPE) attracted over 700 participants to Dublin from 1st to 3rd April 2019. The main topic was “Drive and Leverage Innovation for Pharma”. The Executive Forum focused on the industrial digitisation as a key enabler to drive innovation. Driving continuous improvement in a digital age needs a number of pre-requisites and face new challenges and opportunities.


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30.04.2019 | LOGFILE Feature 16/2019

How to Manage ICH Q3D Risk Assessments with Change Control Management

How to Manage ICH Q3D Risk Assessments with Change Control Management

9 min. reading time | by Paulino Alonso

 

The ICH Q3D Guideline for Elemental Impurities came into effect on January 2018 for all the products for human use. To date, most of the companies have finished the implementation (maybe not at 100%, but ongoing) and now, the challenge is to keep the reports updated.


read more ...
23.04.2019 | LOGFILE Feature 15/2019

Risk Analysis in the Equipment Life Cycle

Risk Analysis in the Equipment Life Cycle

5 min. reading time | by Ulrike Reuter

 

Significance of risk analysis for a qualification

A risk analysis is a fundamental element of a qualification because the content and extent of the qualification tasks are determined therein.


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16.04.2019 | LOGFILE Feature 14/2019

The answer is? FDA publishes final data integrity Q&A

The answer is? FDA publishes final data integrity Q&A

7 min. reading time |

Introduction

Despite much discussion about the subject over the past three years in particular, data integrity issues remain a common feature on 483 letters issued by the U.S. Food and Drug Administration and data handling matters are also a focus of enforcement actions (as well as inspection findings from other regulatory agencies).


read more ...
09.04.2019 | LOGFILE Feature 13/2019

Calibration of Laboratory Instruments

Calibration of Laboratory Instruments

5 min. reading time | by Josef Künzle

 

Change analysis (CA)

The calibration of analytical instruments is stipulated in the GMP Guidelines.


read more ...
02.04.2019 | LOGFILE Feature 12/2019

Clean air in non-sterile production areas

Clean air in non-sterile production areas

8 min. reading time | by Doris Borchert

 

There are no regulatory requirements for the definition of air quality and its monitoring in non-sterile production areas. The topic was discussed by our team of experts and in some cases very different answers were received. The different points of view made us curious - how is this question solved in pharmaceutical practice?


read more ...
27.03.2019 | LOGFILE Feature 11/2019

Risk Analysis of a Pharmaceutical Water System

Risk Analysis of a Pharmaceutical Water System

5 min. reading time | by Fritz Röder

 

As in the case of all qualifications, the risk analysis is carried out to consolidate the knowledge of all the parties involved and define the necessary test and action points required for the qualification. This is an extremely time-consuming process.


read more ...
19.03.2019 | LOGFILE Feature 10/2019

Areas of Application for E-Learning and Advantages of E-Learning

Areas of Application for E-Learning and Advantages of E-Learning

4 min. reading time | by Christine Oechslein

 

E-learning can be seen as didactically meaningful support in the learning process. More and more people prefer to use their PCs and the internet instead of attending seminars or reading documents. The younger generation in particular, who grew up with computers, can absorb a lot of learning content better and faster through e-learning, or can already work out familiar contents in addition.


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05.03.2019 | LOGFILE Feature 08/2019

New Technologies for Cleanroom Planning

New Technologies for Cleanroom Planning

4 min. reading time | by Harald Flechl

 

A cost-optimized approach to project planning and execution, including the use of BIM (Building Information Modelling), will be used increasingly in the future. If this technology is applied correctly and over the entire project sequence, it makes it possible to optimise the planning, execution and usage of buildings, furnishings and installations using digitally prepared product data and software.


read more ...
26.02.2019 | LOGFILE Feature 07/2019

Annex 1 - Sterile and Aseptic Production Facing New Challenges

Annex 1 - Sterile and Aseptic Production Facing New Challenges

8 min. reading time | by Dr. Sabine Paris

 

The new Annex 1 of the EU GMP Guide is to be finalised in December 2018. The publication is planned for spring 2019. Which changes will surely come, where is there still a need for discussion? Where are your ambiguities?


read more ...
19.02.2019 | LOGFILE 06/2019

The GMP Regulations Report 2018

The GMP Regulations Report 2018

9 min. reading time | by Sabine Rabus

 

This summary review of GMP documents published in 2018 provides an overview on developments in important international legislation and regulations.


read more ...
05.02.2019 | LOGFILE Feature 05/2019

GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

4 min. reading time | by Cornelia Wawretschek

 

Personnel


read more ...
22.01.2019 | LOGFILE Feature 03/2019

Microbiological Monitoring: Actions when levels are exceeded

Microbiological Monitoring: Actions when levels are exceeded

5 min. reading time | by Hanfried Seyfarth

 

Actions to be taken when levels are exceeded and the related responsibilities should be described in detail in a separate SOP. The Monitoring SOP should include a reference to this SOP.


read more ...
04.12.2018 | LOGFILE Feature 01/2019

Qualification and Validation: Agency Expectations – Design Qualification (DQ)

Qualification and Validation: Agency Expectations – Design Qualification (DQ)

5 min. reading time | by Michael Hiob

 

The qualification of equipment and machinery is performed throughout its lifecycle (see Figure 1).


read more ...
27.11.2018 | LOGFILE Feature 46/2018

Product Transfer Challenges

Product Transfer Challenges

4 min. reading time | by Christian Gausepohl

 

Certain questions and challenges keep recurring during product transfers. It is important to anticipate them systematically and put appropriate preventive measures in place. The critical issues include:


read more ...
13.11.2018 | LOGFILE Feature 45/2018

GDP Questionnaire – Incoming goods

GDP Questionnaire – Incoming goods

5 min. reading time | by Simone Ferrante


read more ...
06.11.2018 | LOGFILE Feature 44/2018

What is quality management?

What is quality management?

5 min. reading time | by Christine Oechslein

 

Why is it necessary to "manage" quality?


read more ...
30.10.2018 | LOGFILE Feature 42/2018

The Structure of Electronic Document Management and Quality Management Systems (EDMS/EQMS)

The Structure of Electronic Document Management and Quality Management Systems (EDMS/EQMS)

5 min. reading time | by Thilo Gukelberger

 

An EDMS is typically used to store the following information units:


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30.10.2018 | LOGFILE Feature 43/2018

Paradigm shift in the establishment of limits for the validation of cleaning processes

Paradigm shift in the establishment of limits for the validation of cleaning processes

5 min. reading time | by Jens Hrach

 

Requirements for the establishment of limit values first appeared in the FDA Guide to Inspections of Validation of Cleaning Processes in 1993:


read more ...
23.10.2018 | LOGFILE Feature 41/2018

Inspection of Process Validation

Inspection of Process Validation

6 min. reading time

 

GMP Requirements for Process Validation


read more ...
16.10.2018 | LOGFILE Feature 40/2018

Ventilation units, or the invisible energy in the clean room

Ventilation units, or the invisible energy in the clean room

9 min. reading time | by Doris Borchert

 

Ventilation units are the heart of cleanrooms. They enable the air to circulate in the same way as the heart enables the blood to do so in the human body.


read more ...
09.10.2018 | LOGFILE Feature 39/2018

Batch release process steps

Batch release process steps

6 min. reading time | by Rainer Gnibl

 

The actual batch release procedure for finished products can be subdivided into three steps. These build up on each other and should be carried out chronologically.


read more ...
09.10.2018 | LOGFILE Feature 38/2018

Blockchain: Will it Transform the Pharmaceutical Supply Chain?

Blockchain: Will it Transform the Pharmaceutical Supply Chain?

6 min. reading time | by Mark Crawford

 

The pharmaceutical supply chain is becoming an increasingly complex system, making it harder for drug manufacturers and their partners to ensure safe and timely delivery. Keeping track of products is not always a transparent process.


read more ...
25.09.2018 | LOGFILE Feature 37/2018

What is the point of "heating" medicinal products to 15–25 °C?

What is the point of "heating" medicinal products to 15–25 °C?

6 min. reading time | by Christoph Frick

 

There is no legal, ecological or pharmaceutical reason why a preparation should be heated from 12 °C (the outside temperature), for example, to a constant temperature of 20 °C (i.e. the mean of 15–25 °C) and stored at this temperature.


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20.09.2018 | LOGFILE Feature 36/2018

Calibration of Laboratory Instruments

Calibration of Laboratory Instruments

5 min. reading time | by Josef Künzle

 

Change analysis (CA)


read more ...
13.09.2018 | LOGFILE Feature 35/2018

Quality Oversight and Lean QA

Quality Oversight and Lean QA

6 min. reading time | by Susanne Sailer

 

Quality Oversight and Lean QA – two terms that have been making the rounds for years:


read more ...
04.09.2018 | LOGFILE Feature 34/2018

Failure Management in a GMP Regulated Environment

Failure Management in a GMP Regulated Environment

5 min. reading time | by Martin Mayer

 

Change analysis (CA)


read more ...
29.08.2018 | LOGFILE Feature 33/2018

Regulatory Update at the PDA European Annual Meeting

Regulatory Update at the PDA European Annual Meeting

6 min. reading time | by Thomas Peither

 

Outstanding! This is my one-word summary for the PDA European Annual Meeting 2018. The second plenary session focused on regulatory progress and the discussion gave some insights into upcoming topics.


read more ...
22.08.2018 | LOGFILE Feature 32/2018

Risk Analysis of a Pharmaceutical Water System

Risk Analysis of a Pharmaceutical Water System

5 min. reading time | by Fritz Röder

 

As in the case of all qualifications, the risk analysis is carried out to consolidate the knowledge of all the parties involved and define the necessary test and action points required for the qualification.


read more ...
03.08.2018 | LOGFILE Feature 31/2018

Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing

Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing

12 min. reading time | by Fritz Röder

 

The new draft of Annex 1 of the EU GMP Guidelines keeps numerous responsible persons in the pharmaceutical industry busy. Are you already prepared for the possible changes?


read more ...
26.07.2018 | LOGFILE Feature 30/2018

GMP Requirements for Process Validation

GMP Requirements for Process Validation

12 min. reading time


read more ...
23.07.2018 | LOGFILE Feature 29/2018

Data Integrity in the Pharmaceutical Industry

Data Integrity in the Pharmaceutical Industry

14 min. reading time | by Gary Bird

 

Data integrity has become the most recent inspectional “buzz word” in the pharmaceutical industry. Over the last 6 to 8 years, the focus on data reliability has hit an all-time high with regulatory authorities across the globe. This has resulted in numerous regulatory actions.


read more ...
05.07.2018 | LOGFILE Feature 28/2018

Executing Sterile Filtration

Executing Sterile Filtration

6 min. reading time | by Ruven Brandes

 

When performing sterile filtration of a solution, it is recommended that a SOP describing all required components of the equipment and accessories should be used in order to ensure that no steps are omitted.


read more ...
02.07.2018 | LOGFILE Feature 27/2018

Pharmaceutical Industry Highlights - Past, Present, Future

Pharmaceutical Industry Highlights - Past, Present, Future

6 min. reading time | by Thomas Peither

 

Outstanding! This is my one-word summary for the PDA European Annual Meeting 2018. In this first article you will read about the plenary session on Pharmaceutical Industry Highlights - Past, Present, Future, and get snapshots of topics presented on 26 and 27 June in Berlin.


read more ...
22.06.2018 | LOGFILE Feature 26/2018

Principles of Cleaning Process Requirements

Principles of Cleaning Process Requirements

6 minutes reading time | by Michael Hiob

 

Cleaning processes should remove residues from surfaces that come in contact with the product to prevent the cross-contamination of subsequent products.


read more ...
15.06.2018 | LOGFILE Feature 25/2018

The clock is ticking on the new EU Medical Devices and In Vitro Diagnostic Devices Regulations

The clock is ticking on the new EU Medical Devices and In Vitro Diagnostic Devices Regulations

10 min. reading time | by Andrew Love

 

Following approval in March 2017 by the European Council and in April 2017 by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 – were published in the Official Journal of the European Union on 5 May 2017 [1,2].


read more ...
11.06.2018 | LOGFILE Feature 24/2018

GDP Questionnaire – Transportation

GDP Questionnaire – Transportation

5 min. reading time | by Simone Ferrante


read more ...
17.05.2018 | LOGFILE Feature 23/2018

PQ: The Link between Qualification and Validation

PQ: The Link between Qualification and Validation

6 min. reading time | by Thomas Peither, Ulrike Reuter, Rainer Röcker

 

During a Performance Qualification (PQ) the proper interaction of the previously tested units of a complete equipment line or plant is tested, such as for an HVAC system, a purified water plant and filling or packaging lines.


read more ...
16.05.2018 | LOGFILE Feature 22/2018

Data Integrity and the Problem of Getting It Done

Data Integrity and the Problem of Getting It Done

8 min. reading time | by Thomas Peither

 

When it comes to data integrity: What are the current regulatory expectations? How do you ensure the reliability of your suppliers? Do you understand the impact of culture on your organisation?


read more ...
07.05.2018 | LOGFILE Feature 21/2018

Effectively Dealing with OOX Results

Effectively Dealing with OOX Results

7 min. readingtime | by Dr. Markus Limberger

 

The main objective of the pharmaceutical industry when manufacturing and testing active ingredients, excipients and proprietary medicinal products is to guarantee the quality and safety of the product and thus the safety of the patient.


read more ...
02.05.2018 |

LOGFILE No. 17/2018 – Layout of a Cleanroom Air Handling Unit

LOGFILE No. 17/2018 – Layout of a Cleanroom Air Handling Unit

Layout of a Cleanroom Air Handling Unit

 

An excerpt from the GMP Compliance Adviser, Chapter 3.I Air Handling Technology

 

6 minutes reading time

by Harald Flechl


read more ...
27.04.2018 |

LOGFILE No. 20/2018 – Practical Issues on Supply Chain and Good Distribution Practice

LOGFILE No. 20/2018 – Practical Issues on Supply Chain and Good Distribution Practice

Practical Issues on Supply Chain and Good Distribution Practice

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

6 minutes reading time

by Susanne Sailer


read more ...
19.04.2018 |

LOGFILE No. 19/2018 – 2017 - The GMP Regulations Report

LOGFILE No. 19/2018 – 2017 - The GMP Regulations Report

2017 – The GMP Regulations Report

by Sabine Rabus


read more ...
16.04.2018 |

LOGFILE No. 18/2018 – The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

LOGFILE No. 18/2018 – The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither


read more ...
09.04.2018 |

LOGFILE No. 16/2018 – Industry 4.0 - Inspiration for the Pharmaceutical Industry?

LOGFILE No. 16/2018 – Industry 4.0 - Inspiration for the Pharmaceutical Industry?

Industry 4.0 - Inspiration for the Pharmaceutical Industry?

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither


read more ...
03.04.2018 |

LOGFILE No. 15/2018 – Principles of Qualification

LOGFILE No. 15/2018 – Principles of Qualification

Principles of Qualification

An excerpt from the GMP Series PDF Download Qualification and Validation: Agency Expectations

6 minutes reading time

by Michael Hiob, PhD


read more ...
26.03.2018 |

LOGFILE No. 14/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 2

LOGFILE No. 14/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 2

Inspections & Audits: Pitfalls and Criteria for Success – Part 2

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

6 minutes reading time

by Sabine Rabus and Christine Gräßlin


read more ...
13.03.2018 |

LOGFILE No. 10/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 1

LOGFILE No. 10/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 1

What a Qualified Person must know about the recent cleaning validation updates – Part 1

6 minutes reading time

by Walid El Azab


read more ...
12.03.2018 |

LOGFILE No. 13/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 1

LOGFILE No. 13/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 1

Inspections & Audits: Pitfalls and Criteria for Success – Part 1

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

4 minutes reading time

by Sabine Rabus and Christine Gräßli


read more ...
06.03.2018 |

LOGFILE No. 09/2018 – General principles of hygienic design

LOGFILE No. 09/2018 – General principles of hygienic design

General principles of hygienic design

An excerpt from the GMP Series PDF Download Applying the Principles of Hygienic Design to Solid Dosage Forms

8 minutes reading time

by Richard Denk


read more ...
05.03.2018 |

LOGFILE No. 12/2018 – Sampling Frequencies

LOGFILE No. 12/2018 – Sampling Frequencies

Sampling Frequencies

An excerpt from the GMP Series PDF Download Microbiological Monitoring in Pharmaceutical Manufacturing

6 minutes reading time

by Hanfried Seyfarth, PhD


read more ...
27.02.2018 |

LOGFILE No. 08/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2

LOGFILE No. 08/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2

What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2

6 minutes reading time

A commentary by Ruven Brandes and Fritz Röder


read more ...
22.02.2018 |

LOGFILE No. 11/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 2

LOGFILE No. 11/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 2

What a Qualified Person must know about the recent cleaning validation updates – Part 2

6 minutes reading time

by Walid El Azab


read more ...
21.02.2018 |

LOGFILE No. 07/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

LOGFILE No. 07/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

6 minutes reading time

A commentary by Ruven Brandes and Fritz Röder


read more ...
06.02.2018 |

LOGFILE No. 05/2018 – Implementing and Monitoring Data Integrity Measures

LOGFILE No. 05/2018 – Implementing and Monitoring Data Integrity Measures

Implementing and Monitoring Data Integrity Measures

An excerpt from the GMP Focus PDF Download Data Integrity in the EU

5 minutes reading time

by Markus Veit, PhD


read more ...
30.01.2018 |

LOGFILE No. 04/2018 – Key learnings from serialisation projects – Part 2

LOGFILE No. 04/2018 – Key learnings from serialisation projects – Part 2

Key learnings from serialisation projects – Part 2

6 minutes reading time

by Andrew Love and Stephen McIndoe


read more ...
23.01.2018 |

LOGFILE No. 03/2018 – Key learnings from serialisation projects – Part 1

LOGFILE No. 03/2018 – Key learnings from serialisation projects – Part 1

Key learnings from serialisation projects – Part 1

6 minutes reading time

by Andrew Love and Stephen McIndoe

 

 


read more ...
16.01.2018 |

LOGFILE No. 02/2018 – Risk Analysis in the Equipment Life Cycle

LOGFILE No. 02/2018 – Risk Analysis in the Equipment Life Cycle

Risk Analysis in the Equipment Life Cycle

An excerpt from the GMP Focus PDF Download Principles of Equipment Qualification

5 minutes reading time

by Ulrike Reuter


read more ...
12.01.2018 |

LOGFILE No. 06/2018 – Root Cause Analysis – An Essential Enabler

LOGFILE No. 06/2018 – Root Cause Analysis – An Essential Enabler

Root Cause Analysis – An Essential Enabler

An excerpt from the GMP Compliance Adviser, Chapter 20.E Failure Management

8 minutes reading time

by Martin Mayer


read more ...
09.01.2018 |

LOGFILE No. 01/2018 – Ask Our Experts – Part 2 – 4 GMP-Questions which might be of your interest

LOGFILE No. 01/2018 – Ask Our Experts – Part 2 – 4 GMP-Questions which might be of your interest

Ask Our Experts – Part 2

4 GMP-Questions which might be of your interest

7 minutes reading time

by Sabine Rabus


read more ...
05.12.2017 |

LOGFILE No. 46/2017 – International GMP – Six Questions for Jacques Morénas

LOGFILE No. 46/2017 – International GMP – Six Questions for Jacques Morénas

International GMP – Six Questions for Jacques Morénas

5 minutes reading time


read more ...
21.11.2017 |

LOGFILE No. 44/2017 – Intermediate Bulk Container Systems

LOGFILE No. 44/2017 – Intermediate Bulk Container Systems

Intermediate Bulk Container Systems

An excerpt from the GMP Series PDF Download Technical Solutions for Personal Protection in Solid Drug Manufacturing

5 minutes reading time

by Richard Denk


read more ...
14.11.2017 | LOGFILE No. 43/2017

Indispensable: The Determination of PDE Values as Exposure Limits

Indispensable: The Determination of PDE Values as Exposure Limits

Indispensable: The Determination of PDE Values as Exposure Limits for Risk Analysis in Shared Facilities

It is not possible to estimate the danger or toxicity of APIs only according to their therapeutic group.
Results of an analysis of 1200 active substances.

8 minutes reading time

by Beatriz Carrero, PhD, Azierta and Sabine Paris, PhD, Maas & Peither – GMP Publishing


read more ...
10.11.2017 |

LOGFILE No. 42/2017 – Final version of the EMA Q&A paper on WFI production without distillation

LOGFILE No. 42/2017 – Final version of the EMA Q&A paper on WFI production without distillation

Update: Final version of the EMA Q&A paper on WFI production without distillation

5 minutes reading time

by Fritz Röder


read more ...
31.10.2017 |

LOGFILE No. 41/2017 – Deviation Management

LOGFILE No. 41/2017 – Deviation Management

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl


read more ...
24.10.2017 |

LOGFILE No. 40/2017 – Calibration of laboratory instruments

LOGFILE No. 40/2017 – Calibration of laboratory instruments

Calibration of laboratory instruments

An excerpt of the GMP Compliance AdviserChapter 14.D.4

5 minutes reading time

by Josef Künzle, PhD, Wolfgang Nedvidek, PhD


read more ...
24.10.2017 |

LOGFILE No. 47/2017 – Ask Our Experts – Part 1 – 6 GMP-Questions which might be of interest to You

LOGFILE No. 47/2017 – Ask Our Experts – Part 1 – 6 GMP-Questions which might be of interest to You

Ask Our Experts – Part 1

6 GMP-Questions which might be of interest to you

7 minutes reading time

by Sabine Rabus


read more ...
17.10.2017 |

LOGFILE No. 39/2017 – Mobile water treatment possible even in the GMP area for the first time!

LOGFILE No. 39/2017 – Mobile water treatment possible even in the GMP area for the first time!

Mobile water treatment possible even in the GMP area for the first time!

6 minutes reading time

by Fritz Röder


read more ...
16.10.2017 |

LOGFILE No. 45/2017 – 8 Golden Rules for Personnel Hygiene

LOGFILE No. 45/2017 – 8 Golden Rules for Personnel Hygiene

8 Golden Rules for Personnel Hygiene

An excerpt from the GMP Compliance AdviserChapter 11.B.5

4 minutes reading time

by Christian Gausepohl, PhD


read more ...
10.10.2017 |

LOGFILE No. 38/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

LOGFILE No. 38/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

6 minutes reading time

by Dr. Tim Sandle


read more ...
04.10.2017 |

LOGFILE No. 37/2017 – Physical monitoring of cleanrooms

LOGFILE No. 37/2017 – Physical monitoring of cleanrooms

Physical monitoring of cleanrooms

An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht


read more ...
26.09.2017 |

LOGFILE No. 36/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

LOGFILE No. 36/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

6 minutes reading time

by Dr. Tim Sandle


read more ...
19.09.2017 |

LOGFILE No. 35/2017 – Technology Transfer Phases

LOGFILE No. 35/2017 – Technology Transfer Phases

Technology Transfer Phases

An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing

5 minutes reading time

by Christian Gausepohl, PhD


read more ...
12.09.2017 |

LOGFILE No. 34/2017 – Data Integrity – Old Wine in New Skins? – Part 2

LOGFILE No. 34/2017 – Data Integrity – Old Wine in New Skins? – Part 2

Data Integrity – Old Wine in New Skins?

GMP Talk Between the GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 2

7 minutes reading time

by Sabine Paris, PhD


read more ...
05.09.2017 |

LOGFILE No. 33/2017 – Data Integrity – Old Wine in New Skins? – Part 1

LOGFILE No. 33/2017 – Data Integrity – Old Wine in New Skins? – Part 1

Data Integrity – Old Wine in New Skins?

GMP-Talk Between GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 1

7 minutes reading time

by Sabine Paris, PhD


read more ...
29.08.2017 |

LOGFILE No. 32/2017 – Human Resource Management

LOGFILE No. 32/2017 – Human Resource Management

Human Resource Management: Qualification requirements and requirement profiles

An Excerpt from the GMP Series PDF Download Roadmap to Manage Personnel in Pharmaceutical Manufacturing

by Michael Hiob, PhD


read more ...
01.08.2017 |

LOGFILE No. 30/2017 – MRA-EU-USA – Part 2

LOGFILE No. 30/2017 – MRA-EU-USA – Part 2

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 2

5 minutes reading time

by Sabine Paris, PhD


read more ...
25.07.2017 |

LOGFILE No. 29/2017 – MRA-EU-USA – Part 1

LOGFILE No. 29/2017 – MRA-EU-USA – Part 1

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 1

5 minutes reading time

by Sabine Paris, PhD


read more ...
18.07.2017 |

LOGFILE No. 28/2017 – Checklist Performance Qualification

LOGFILE No. 28/2017 – Checklist Performance Qualification

Checklist Performance Qualification

An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification

by Hans H. Schicht, PhD


read more ...
07.07.2017 |

LOGFILE Nr. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

LOGFILE Nr. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD


read more ...
27.06.2017 |

LOGFILE No. 25/2017 – Manufacturing Innovation – PDA Annual Meeting 2017, Anaheim

LOGFILE No. 25/2017 – Manufacturing Innovation – PDA Annual Meeting 2017, Anaheim

Manufacturing Innovation - PDA Annual Meeting 2017, Anaheim

8 min. reading time

by Thomas Peither


read more ...
19.06.2017 |

LOGFILE No. 31/2017 – GMP-Compliance-Index 2017

LOGFILE No. 31/2017 – GMP-Compliance-Index 2017

GMP-Compliance-Index 2017

Join in now and further your knowledge!

by Thomas Peither


read more ...
13.06.2017 |

LOGFILE No. 23/2017 – Changes in USP <1231>: Water for Pharmaceutical Purposes

LOGFILE No. 23/2017 – Changes in USP <1231>: Water for Pharmaceutical Purposes

Changes in USP <1231>: Water for Pharmaceutical Purposes

8 min. reading time

by Fritz Röder


read more ...
31.05.2017 | LOGFILE Feature 21/2017

Quality Agreement – A Sample Document

Quality Agreement – A Sample Document

by Dr. Christine Oechslein


We have prepared for you page 1 and 3 of the document. Please click on the following link to read the excerpt.


read more ...
30.05.2017 | LOGFILE Feature 21/2017

Quality Agreement – A Sample Document

Quality Agreement – A Sample Document

by Dr. Christine Oechslein

 


We have prepared for you page 1 and 3 of the document. Please click on the following link to read the excerpt.


read more ...
23.05.2017 |

LOGFILE No. 20/2017 – 85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

LOGFILE No. 20/2017 – 85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

An excerpt from the GMP Series GMP-Questionnaire: Contract Manufacturing / Contract Analysis

by Dr. Christine Oechslein


read more ...
16.05.2017 |

LOGFILE No. 19/2017 – Complex Product and Process Flows

LOGFILE No. 19/2017 – Complex Product and Process Flows

A Challenge: Complex Product and Process Flows

An excerpt from the GMP Compliance Adviser (formerly GMP MANUAL), Chapter 14.J.8 and 14.J.8.1

3 min. reading time

by Rainer Gnibl


read more ...
12.05.2017 |

LOGFILE No. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

LOGFILE No. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD


read more ...
09.05.2017 |

LOGFILE No. 18/2017 – Data Integrity is a Must!

LOGFILE No. 18/2017 – Data Integrity is a Must!

Data Integrity is a Must!

5 min. reading time

A contribution from Thomas Peither


read more ...
03.05.2017 |

LOGFILE No. 17/2017 – Chemical Active Substances - Special Risks

LOGFILE No. 17/2017 – Chemical Active Substances - Special Risks

Chemical Active Substances – Special Risks

An excerpt from the GMP Series Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

4 min. reading time

by Stefan Kettelhoit, PhD


read more ...
25.04.2017 |

LOGFILE No. 16/2017 – 130 Elements You Need for a World-Class Technical Agreement

LOGFILE No. 16/2017 – 130 Elements You Need for a World-Class Technical Agreement

130 Elements You Need for a World-Class Technical Agreement

An excerpt from the GMP Series Technical Agreement and Delimitation of Pharmaceutical Responsibilities

by Dr. Christine Oechslein


read more ...
18.04.2017 |

LOGFILE No. 15/2017 – Formalizing a Risk Assessment for Excipients

LOGFILE No. 15/2017 – Formalizing a Risk Assessment for Excipients

Formalizing a Risk Assessment for Excipients

by Frithjof Holtz

 


read more ...
04.04.2017 |

LOGFILE No. 13/2017 - Comment to the Revision of the Note for Guidance on Quality of Water for Pharmaceutical Use

LOGFILE No. 13/2017 - Comment to the Revision of the Note for Guidance on Quality of Water for Pharmaceutical Use

“Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)”

A comment by Fritz Röder and Ruven Brandes

(reading time 5 min)

by Fritz Röder and Ruven Brandes


read more ...
31.03.2017 |

LOGFILE No. 22/2017 – Independent and Linked CAPA Systems

LOGFILE No. 22/2017 – Independent and Linked CAPA Systems

Independent and Linked CAPA Systems

An excerpt from the GMP Series How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

3 min. reading time

by Dr. Bernd Renger


read more ...
29.03.2017 |

LOGFILE No. 12/2017 - Document Access for GMP inspectors and Auditors of Notified Bodies

LOGFILE No. 12/2017 - Document Access for GMP inspectors and Auditors of Notified Bodies

Document Access for GMP Inspectors and Auditors of Notified Bodies

Your question – our answer – Part 2

(5 min. reading time)

by Dr. Sabine Paris


read more ...
21.03.2017 |

LOGFILE No. 11/2017 – 24 GMP documents you should know about

LOGFILE No. 11/2017 – 24 GMP documents you should know about

 

24 GMP documents You Should Know About–

A Concise Review of Everything New in 2016

by Sabine Rabus


read more ...
14.03.2017 |

LOGFILE No. 10/2017 – What do GMP compliance and GEP mean?

LOGFILE No. 10/2017 – What do GMP compliance and GEP mean?

What do GMP compliance and GEP mean?

An excerpt from the GMP Compliance Adviser

(4 min. reading time)

by Thomas Peither


read more ...
07.03.2017 |

LOGFILE No. 09/2017 - The Process of Freeze-Drying

LOGFILE No. 09/2017 - The Process of Freeze-Drying

Temperature monitoring and control

An excerpt from the GMP Series The Process of Freeze-Drying

(3 min. reading time)

by Dr. Margit Gieseler

 


read more ...
21.02.2017 |

LOGFILE No. 07/2017 – Executing Sterile Filtration

LOGFILE No. 07/2017 – Executing Sterile Filtration

Executing Sterile Filtration

An excerpt from the GMP Series download Aseptic Processing of Sterile Medicinal Products

by Ruven Brandes


read more ...
07.02.2017 |

LOGFILE No. 05/2017 – Sampling Frequencies

LOGFILE No. 05/2017 – Sampling Frequencies

Sampling Frequencies

An excerpt from the GMP Series download Microbiological Monitoring in Pharmaceutical Manufacturing

by Dr. Hanfried Seyfarth


read more ...
31.01.2017 |

LOGFILE No. 04/2017 – Managing Outsourced GMP Activities Successfully

LOGFILE No. 04/2017 – Managing Outsourced GMP Activities Successfully

Managing Outsourced GMP Activities Successfully

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher and Dr. jur. Ingo Schneider


read more ...
30.01.2017 |

LOGFILE No. 14/2017 - 170 Questions You Should Ask Your Supplier

LOGFILE No. 14/2017 - 170 Questions You Should Ask Your Supplier

170 Questions You Should Ask Your Supplier

An excerpt from the GMP Series GMP Supplier Assessment Questionnaire

3 min. reading time

by Cornelia Wawretschek

 


read more ...
24.01.2017 |

LOGFILE No. 03/2016 - Limit Values for Cleaning Processes - Part 2

LOGFILE No. 03/2016 - Limit Values for Cleaning Processes - Part 2

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 2

(5 min. reading time)

by Dr. Sabine Paris

 


read more ...
17.01.2017 |

LOGFILE No. 02/2017 - Limit Values for Cleaning Processes - Part 1

LOGFILE No. 02/2017 - Limit Values for Cleaning Processes - Part 1

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 1

(5 min. reading time)

by Dr. Sabine Paris

 


read more ...
10.01.2017 |

LOGFILE No. 01/2017 - Alert and action levels and specifications

LOGFILE No. 01/2017 - Alert and action levels and specifications

Alert and action levels and specifications

An excerpt from the USP <1231> Download

by Fritz Röder


read more ...
06.12.2016 |

LOGFILE No. 45/2016 – Rework: What has to be observed?

LOGFILE No. 45/2016 – Rework: What has to be observed?

Rework: What has to be observed?

An excerpt from the GMP MANUAL

by Dr. Christian Gausepohl


read more ...
22.11.2016 | LOGFILE No. 43/2016

LOGFILE No. 43/2016 – Line Clearance

LOGFILE No. 43/2016 – Line Clearance

Line Clearance

An excerpt from the GMP Series download GMP Compliance Basics of Packaging Materials and Processes

by Ruven Brandes, Dr. Christian Gausepohl


read more ...
15.11.2016 | LOGFILE No. 42/2016

LOGFILE No. 42/2016 – Transport Validation

LOGFILE No. 42/2016 – Transport Validation

Transport Validation

An excerpt from the GMP Focus download Creating a Master Plan for Drug Warehousing, Transportation and Distribution

by Dr. Christoph Frick, Dr. Nicola Spiggelkötter

 


read more ...
11.11.2016 |

LOGFILE No. 08/2017 – Self-Inspection Q&A

LOGFILE No. 08/2017 – Self-Inspection Q&A

Self-Inspection Q&A

(4 min. reading time)

by Dr. Doris Borchert and Dr. Sabine Paris


read more ...
08.11.2016 |

LOGFILE No. 41/2016 – The qualification life cycle concept and tools: an overview

LOGFILE No. 41/2016 – The qualification life cycle concept and tools: an overview

The qualification life cycle concept and tools: an overview

An excerpt from the GMP MANUAL

by Ulrike Reuter


read more ...
18.10.2016 |

LOGFILE No. 39/2016 – Managing Process Validation

LOGFILE No. 39/2016 – Managing Process Validation

Validation Planning

An excerpt from the GMP Focus download Managing Process Validation: A Drugmaker's Guide

by Dr. Christine Oechslein

 


read more ...
11.10.2016 |

LOGFILE No. 38/2016 – PDA/FDA Joint Regulatory Conference 2016

LOGFILE No. 38/2016 – PDA/FDA Joint Regulatory Conference 2016

Evolution and a Touch of GMP Revolution at the PDA/FDA JRC 2016

(Reading time 5 min + 3 min video)

by Thomas Peither


read more ...
05.10.2016 |

LOGFILE No. 37/2016 - Preparing for the EU GMP Inspection

LOGFILE No. 37/2016 - Preparing for the EU GMP Inspection

Self-Inspection

An excerpt from the GMP Focus PDF Download Preparing for the EU GMP Inspection

by Dr. Christian Gausepohl and Max Lazar

 


read more ...
27.09.2016 |

LOGFILE No. 36/2016 – Draft EMA Q&A paper on production of WFI non-distillation methods

LOGFILE No. 36/2016 – Draft EMA Q&A paper on production of WFI non-distillation methods

Not yet all clear: Draft EMA Q&A paper on production of WFI by non-distillation methods

An interview with Fritz Röder


read more ...
20.09.2016 |

LOGFILE No. 35/2016 – Successful Handling of OOX Results

LOGFILE No. 35/2016 – Successful Handling of OOX Results

Receiving the OOS result and starting the OOS process

An Excerpt from the GMP Series PDF Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger


read more ...
13.09.2016 |

LOGFILE No. 34/2016 – The Changing Concept of Validation

LOGFILE No. 34/2016 – The Changing Concept of Validation

The changing concept of validation

An excerpt from the GMP MANUAL

by Dr. Christine Oechslein


read more ...
02.09.2016 |

LOGFILE No. 33/2016 – Achieving “Quality beyond Compliance” is a Matter of Leadership

LOGFILE No. 33/2016 – Achieving “Quality beyond Compliance” is a Matter of Leadership

Achieving “Quality beyond Compliance” is a Matter of Leadership

by Thomas Peither


read more ...
02.09.2016 |

LOGFILE No. 46/2016 - Quality Metrics - What will the FDA require in the future? How are companies already benefitting today?

LOGFILE No. 46/2016 - Quality Metrics - What will the FDA require in the future? How are companies already benefitting today?

Quality Metrics – What will the FDA require in the future? How are companies already benefitting today?

(5 min. reading time)

by Dr. Sabine Paris


read more ...
23.08.2016 |

LOGFILE No. 31/2016 – Separate Device Specification for the FDA?

LOGFILE No. 31/2016 – Separate Device Specification for the FDA?

Separate Device Specification for the FDA?
Your question - our answer

by Thomas Peither


read more ...
15.08.2016 |

LOGFILE No. 44/2016 – Managing Contract Maufacturers and Testing Labs

LOGFILE No. 44/2016 – Managing Contract Maufacturers and Testing Labs

Managing Contract Manufacturers and Testing Labs

An excerpt from the GMP Focus download Managing Contract Manufacturers and Testing Labs

by Dr. Christian Gausepohl, Dr. Frank Böttcher


read more ...
02.08.2016 |

LOGFILE No. 30/2016 – Don’t Be a Daredevil When Retrofitting Your Facility

LOGFILE No. 30/2016 – Don’t Be a Daredevil When Retrofitting Your Facility

Don’t Be a Daredevil When Retrofitting Your Facility

by Bob Ferer


read more ...
19.07.2016 |

LOGFILE No. 28/2016 – Roadmap to Manage Personnel in Pharmaceutical Manufacturing

LOGFILE No. 28/2016 – Roadmap to Manage Personnel in Pharmaceutical Manufacturing

Roadmap to Manage Personnel in Pharmaceutical Manufacturing

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Michael Hiob


read more ...
12.07.2016 |

LOGFILE No. 27/2016 – Quality Management System - What should it cover?

LOGFILE No. 27/2016 – Quality Management System - What should it cover?

What typical situations must be controlled by a quality management system?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein


read more ...
05.07.2016 |

LOGFILE No. 26/2016 – Basic Principles of a DMS

LOGFILE No. 26/2016 – Basic Principles of a DMS

Basic Principles of a Document Management System (DMS)

Excerpt from the GMP Series pdf download
Successful Implementation of Electronic Document Management Systems


by Markus Roemer


read more ...
28.06.2016 |

LOGFILE No. 25/2016 – Change Control – Dealing with Changes in Investigational Medicinal Products

LOGFILE No. 25/2016 – Change Control – Dealing with Changes in Investigational Medicinal Products

Change Control – Dealing with Changes in Investigational Medicinal Products

by Kerstin Kruithoff-Ley


read more ...
21.06.2016 |

LOGFILE No. 24/2016 – System types by extent of automation

LOGFILE No. 24/2016 – System types by extent of automation

System types by extent of automation

Excerpt from the GMP Series pdf download Electronic Batch Recording for Drugmakers


by Markus Roeme


read more ...
14.06.2016 |

LOGFILE No. 23/2016 – Overview of the New USP <1231> Water for Pharmaceutical Purposes

LOGFILE No. 23/2016 – Overview of the New USP <1231> Water for Pharmaceutical Purposes

Overview of the New USP <1231>

Water for Pharmaceutical Purposes

by Fritz Röder


read more ...
19.05.2016 |

LOGFILE No. 20/2016 – Quality Metrics - Bane or Boon?

LOGFILE No. 20/2016 – Quality Metrics - Bane or Boon?

Quality Metrics – Bane or Boon?

GMP Talk with Experts Claudia Pachl and Ruven Brandes

by Dr. Sabine Paris


read more ...
17.05.2016 |

LOGFILE No. 19/2016 – Microbiological monitoring of cleanrooms – regulatory requirements

LOGFILE No. 19/2016 – Microbiological monitoring of cleanrooms – regulatory requirements

Microbiological monitoring of cleanrooms – regulatory requirements

Excerpt from the GMP Series pdf download Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht


read more ...
10.05.2016 |

LOGFILE No. 18/2016 – Problems with the Regulatory Culture

LOGFILE No. 18/2016 – Problems with the Regulatory Culture

Problems with the Regulatory Culture

by Robert G. Kieffer, Ph.D.


read more ...
03.05.2016 |

LOGFILE No. 17/2016 – Air cleanliness grades and associated process steps

LOGFILE No. 17/2016 – Air cleanliness grades and associated process steps

Air cleanliness grades and associated process steps

Excerpt from the GMP Series pdf download Classes and Grades for Air Cleanliness

by Dr. Hans H. Schicht


read more ...
25.04.2016 |

LOGFILE No. 16/2016 – Work instructions, records and documentation

LOGFILE No. 16/2016 – Work instructions, records and documentation

Work instructions, records and documentation –
How do you keep track?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein


read more ...
15.04.2016 |

LOGFILE No. 15/2016 – The New Annex 16 – Eight Questions for Dr. Rainer Gnibl

LOGFILE No. 15/2016 – The New Annex 16 – Eight Questions for Dr. Rainer Gnibl

The New Annex 16 – Eight Questions for Dr. Rainer Gnibl


read more ...
08.04.2016 |

LOGFILE No. 14/2016 – Laboratory data management systems (LDMS)

LOGFILE No. 14/2016 – Laboratory data management systems (LDMS)

Laboratory data management systems (LDMS)

An excerpt from GMP Series How to design a Laboratory Data Management System

by Dr. Ulf Fuchslueger


read more ...
24.03.2016 |

LOGFILE No. 12/2016 – Cytostatic Safety Cabinets

LOGFILE No. 12/2016 – Cytostatic Safety Cabinets

Specifications for packaging materials

An excerpt from GMP Series Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets

by Andreas Nuhn, Dr. Hans H. Schicht


read more ...
17.03.2016 |

LOGFILE No. 21/2016 – Qualification of Single-Use Component: The Need for Standardization

LOGFILE No. 21/2016 – Qualification of Single-Use Component: The Need for Standardization

Qualification of Single-Use Component: The Need for Standardization

by Christopher Smalley


read more ...
17.03.2016 |

LOGFILE No. 11/2016 – What does the new Annex 1 have in store for us?

LOGFILE No. 11/2016 – What does the new Annex 1 have in store for us?

What does the new Annex 1 have in store for us?

by Thomas Peither, Maas & Peither AG


read more ...
07.12.2015 |

LOGFILE No. 10/2016 – Storage and shelf life of laboratory substances

LOGFILE No. 10/2016 – Storage and shelf life of laboratory substances

Storage and shelf life of laboratory substances

An excerpt from the GMP MANUAL

by Dr. Markus Limberger


read more ...
23.11.2015 |

LOGFILE No. 09/2016 – Specifications for packaging materials

LOGFILE No. 09/2016 – Specifications for packaging materials

Specifications for packaging materials

An excerpt from GMP Series GMP Compliance Basics of Packaging Materials and Processes

by Ruven Brandes, Dr. Christian Gausepohl, Roland Kleissendorf


read more ...
16.11.2015 |

LOGFILE No. 08/2016 – Types of Biotechnological Active Substances

LOGFILE No. 08/2016 – Types of Biotechnological Active Substances

Types of Biotechnological Active Substances

An excerpt from GMP Series Managing GMP Requirements in Biotech API Manufacturing

by Dr. Rainer Gnibl


read more ...
09.11.2015 |

LOGFILE No. 07/2016 – Physical monitoring of cleanrooms

LOGFILE No. 07/2016 – Physical monitoring of cleanrooms

Physical monitoring of cleanrooms

An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments

By Dr. Hans H. Schicht


read more ...
04.11.2015 |

LOGFILE No. 06/2016 – Technology Transfer Phases

LOGFILE No. 06/2016 – Technology Transfer Phases

Technology Transfer Phases

An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing

By Dr. Christian Gausepohl


read more ...
23.10.2015 |

LOGFILE No. 05/2016 – Process Validation

LOGFILE No. 05/2016 – Process Validation

Process Validation – How do I implement the new GMP requirements?

Results of the GMP Conference in 2015

Report by Dr. Sabine Paris


read more ...
13.10.2015 |

LOGFILE No. 04/2016 – Deviation Management

LOGFILE No. 04/2016 – Deviation Management

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl


read more ...
25.09.2015 |

LOGFILE No. 03/2016 – Possible risks of manufacturing and packaging

LOGFILE No. 03/2016 – Possible risks of manufacturing and packaging

Possible risks of manufacturing and packaging

An excerpt from GMP Fundamentals 

by Dr. Christine Oechslein


read more ...
14.09.2015 |

LOGFILE No. 02/2016 – Intermediate bulk container systems

LOGFILE No. 02/2016 – Intermediate bulk container systems

Intermediate bulk container systems

An excerpt from the GMP Series PDF Download 
Technical Solutions for Personal Protection in Solid Drug Manufacturing

An excerpt from the GMP MANUAL

by Richard Denk


read more ...
14.08.2015 |

LOGFILE No. 47/2015 – Transportation

LOGFILE No. 47/2015 – Transportation

How do you transport and store medicinal products? Here is what you have to know!

by Dr. Sabine Paris


read more ...
14.08.2015 |

LOGFILE No. 48/2015 – Managing Outsourced GMP Activities Successfully

LOGFILE No. 48/2015 – Managing Outsourced GMP Activities Successfully

Managing Outsourced GMP Activities Successfully

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher and Dr. jur. Ingo Schneider


read more ...
14.08.2015 |

LOGFILE No. 01/2016 – 2016 - GMP in Production

LOGFILE No. 01/2016 – 2016 - GMP in Production

2016 – GMP in Production

by Thomas Peither


read more ...
10.08.2015 |

LOGFILE No. 45/2015 – Reasons for Outsourcing

LOGFILE No. 45/2015 – Reasons for Outsourcing

Reasons for Outsourcing

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher


read more ...
07.08.2015 |

LOGFILE No. 44/2015 – Organization of audits

LOGFILE No. 44/2015 – Organization of audits

Organization of Audits

An excerpt of the GMP-Audit-Checklist

by Dr. Michael Hiob and Max Lazar


read more ...
03.08.2015 |

LOGFILE No. 43/2015 – Particle Monitoring

LOGFILE No. 43/2015 – Particle Monitoring

Particle Monitoring

An excerpt from the GMP MANUAL

by Thomas von Kahlden


read more ...
22.07.2015 |

LOGFILE No. 42 / 2015 – How to deal with OOX Results

LOGFILE No. 42 / 2015 – How to deal with OOX Results

Receiving the OOS result and starting the OOS process

An Excerpt from the GMP Series PDF Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger


read more ...
20.07.2015 |

LOGFILE No. 41/2015 – Checklist Performance Qualification

LOGFILE No. 41/2015 – Checklist Performance Qualification

Checklist Performance Qualification

An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification

by Dr. Hans H. Schicht


read more ...
07.07.2015 |

LOGFILE No. 40/2015 – The purpose of GMP

LOGFILE No. 40/2015 – The purpose of GMP

The purpose of GMP

An excerpt of GMP Fundamentals

by Dr. Christine Oechslein


read more ...
06.07.2015 |

LOGFILE No. 39/2015 – Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

LOGFILE No. 39/2015 – Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Stefan Kettelhoit


read more ...
23.06.2015 |

LOGFILE No. 37/2015 – How to Manage Corrective and Preventive Actions

LOGFILE No. 37/2015 – How to Manage Corrective and Preventive Actions

How to Manage Corrective and Preventive Actions (CAPA) in GMP Environment

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Bernd Renger


read more ...
15.06.2015 | LOGFILE No. 36/2015

What is quality management?

What is quality management?

What is quality management?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein


read more ...
08.06.2015 |

LOGFILE No. 35/2015 – GMP Inspection: Be Prepared when the Inspector Comes

LOGFILE No. 35/2015 – GMP Inspection: Be Prepared when the Inspector Comes

GMP Inspection: Be Prepared when the Inspector Comes

by Thomas Peither


read more ...
29.05.2015 |

LOGFILE No. 34/2015 – Risk Management in Transportation

LOGFILE No. 34/2015 – Risk Management in Transportation

Risk Management in Transportation

An excerpt of the GMP MANUAL


by Dr. Nicola Spiggelkoetter


read more ...
27.05.2015 |

LOGFILE No. 32/2015 – Older Pharmaceutical Factories

LOGFILE No. 32/2015 – Older Pharmaceutical Factories

Older Pharmaceutical Factories – What does the FDA have to say?

by Thomas Peither

 


read more ...
04.05.2015 |

LOGFILE No. 30/2015 – Quality Metrics - Bane or Boon?

LOGFILE No. 30/2015 – Quality Metrics - Bane or Boon?

Quality Metrics - Bane or Boon?

by Thomas Peither


read more ...
28.04.2015 |

LOGFILE No. 28/2015 - Risk Evaluation - more than just data and facts

LOGFILE No. 28/2015 - Risk Evaluation - more than just data and facts

Risk Evaluation - more than just data and facts

An excerpt from the PDA/DHI publication Risk Assessment and Risk Management in the Pharmaceutical Industry - Clear and Simple

by James L. Vesper


read more ...
21.04.2015 |

LOGFILE No. 26/2015 - General principles of hygienic design

LOGFILE No. 26/2015 - General principles of hygienic design

General principles of hygienic design

An excerpt of the GMP MANUAL


by Richard Denk


read more ...
13.04.2015 |

LOGFILE No. 24/2015 - Cleaning Engineering: Flow and Coverage in Process Piping

LOGFILE No. 24/2015 - Cleaning Engineering: Flow and Coverage in Process Piping

Cleaning Engineering: Flow and Coverage in Process Piping

An excerpt from the PDA/DHI publication Cleaning and Cleaning Validation

by George Verghese and Paul Lopolito


read more ...
31.03.2015 |

LOGFILE No. 22/2015 – Reverse osmosis also allowed for future WFI production

LOGFILE No. 22/2015 – Reverse osmosis also allowed for future WFI production

Reverse osmosis also allowed for future WFI production

An interview with Ruven Brandes

by Dr. Sabine Paris


read more ...
25.03.2015 |

LOGFILE No. 20/2015 – Laboratory data management systems (LDMS)

LOGFILE No. 20/2015 – Laboratory data management systems (LDMS)

Advantages of laboratory data management systems (LDMS)

An excerpt of the GMP MANUAL

by Dr. Ulf Fuchslueger


read more ...
19.03.2015 |

LOGFILE No. 17/2015 – Types of Biotechnological Active Substances

LOGFILE No. 17/2015 – Types of Biotechnological Active Substances

Types of Biotechnological Active Substances

An excerpt of the GMP MANUAL

by Dr. Rainer Gnibl


read more ...
06.03.2015 |

LOGFILE No. 15/2015 – Reduce Human Error in a GMP Facility

LOGFILE No. 15/2015 – Reduce Human Error in a GMP Facility

Reduce Human Error in a GMP Facility

by Claire Newcombe, Applied Biopharm Consultancy, Shanon McKenna , PAREXEL, Anthony Newcombe, PhD, PAREXEL


read more ...
25.02.2015 |

LOGFILE No. 07/2015 - Project management of facility construction

LOGFILE No. 07/2015 - Project management of facility construction

Project management of facility construction

An excerpt of the GMP MANUAL


by Thomas Peither


read more ...
09.02.2015 |

LOGFILE No. 11/2015 - Preventing Cross-Contamination

LOGFILE No. 11/2015 - Preventing Cross-Contamination

Preventing Cross-Contamination

In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances.


by Susanne Sailer


read more ...
09.02.2015 |

LOGFILE No. 13/2015 – Continuous Manufacturing - the FDA Perspective

LOGFILE No. 13/2015 – Continuous Manufacturing - the FDA Perspective

Continuous Manufacturing

– the FDA perspective on the future of medicinal product manufacturing –


by Dr. Sabine Paris


read more ...
02.02.2015 |

LOGFILE No. 09/2015 - Principles of blow-fill-seal technology

LOGFILE No. 09/2015 - Principles of blow-fill-seal technology

Principles of blow-fill-seal technology

An excerpt of the GMP MANUAL


by Dr. Manfred Grüneberg


read more ...
02.02.2015 |

LOGFILE No. 09/2015 - Principles of blow-fill-seal technology

LOGFILE No. 09/2015 - Principles of blow-fill-seal technology

Principles of blow-fill-seal technology

An excerpt of the GMP MANUAL


by Dr. Manfred Grüneberg


read more ...
27.01.2015 |

LOGFILE No. 05/2015 - Qualification and ATP Classification

LOGFILE No. 05/2015 - Qualification and ATP Classification

What you must know about qualification and ATP classification of lorries

by Thomas Peither


read more ...
19.01.2015 |

LOGFILE No. 03/2015 - Effectively dealing with OOX Results

LOGFILE No. 03/2015 - Effectively dealing with OOX Results

Test results outside defined criteria (OOX)

by Dr. Markus Limberger


read more ...
12.01.2015 |

LOGFILE No. 01/2015 - GMP-Outlook 2015

LOGFILE No. 01/2015 - GMP-Outlook 2015

GMP-Outlook 2015: What to expect in the world of GMP?

by Thomas Peither


read more ...
08.12.2014 |

LOGFILE No. 38/2014 - GMP Certificates: What do they prove?

LOGFILE No. 38/2014 - GMP Certificates: What do they prove?

GMP-Compliant Documentation

An excerpt from the GMP MANUAL

by Cornelia Wawretschek


read more ...
17.11.2014 |

LOGFILE No. 36/2014 - EDMF/ASMF and CEP

LOGFILE No. 36/2014 - EDMF/ASMF and CEP

EDMF/ASMF and CEP

An excerpt from the GMP MANUAL

by Dr. Stefan Kettelhoit

 


read more ...
07.11.2014 |

LOGFILE No. 34/2014 - Safety in the workplace

LOGFILE No. 34/2014 - Safety in the workplace

Safety in the workplace / Occupational health and safety

An excerpt from the GMP MANUAL

by Dr. Michael Hiob

 

 


read more ...
31.10.2014 |

LOGFILE No. 28/2014 - Integrated Quality Risk Management

LOGFILE No. 28/2014 - Integrated Quality Risk Management

Integrated Quality Risk Management

An excerpt from the GMP MANUAL

by Martin Mayer


read more ...
27.10.2014 |

LOGFILE No. 24/2014 - Risk Assessment of Excipients

LOGFILE No. 24/2014 - Risk Assessment of Excipients

Excipients – Risks and their Assessment

by Dr. Stephanie Blum


read more ...
20.10.2014 |

LOGFILE No. 22/2014 - Electronic Training Systems

LOGFILE No. 22/2014 - Electronic Training Systems

Electronic Training Systems

An excerpt from the GMP MANUAL

by Dr. Michael Hiob


read more ...
20.10.2014 |

LOGFILE No. 20/2014 - Quality Assurance

LOGFILE No. 20/2014 - Quality Assurance

The Role of Quality Assurance within the Pharmaceutical Quality System

by Dr. Bernd Renger


read more ...
14.10.2014 |

LOGFILE No. 18/2014 - Knowledge Management

LOGFILE No. 18/2014 - Knowledge Management

Knowledge Management is the Next Risk Management

by Thomas Peither


read more ...
06.10.2014 |

LOGFILE No. 16/2014 - EU GMP-Guide Revisions

LOGFILE No. 16/2014 - EU GMP-Guide Revisions

How do new developments find their way into the EU GMP Guide?

What is the present status of the revision of the EU GMP Guide?

by Dr. Sabine Paris


read more ...
29.09.2014 |

LOGFILE No. 14/2014 - Quality is more than GMP Compliance

LOGFILE No. 14/2014 - Quality is more than GMP Compliance

There's More to Quality than GMP Compliance

by Thomas Peither


read more ...
22.09.2014 |

LOGFILE No. 10/2014 - Preventing Cross-Contamination

LOGFILE No. 10/2014 - Preventing Cross-Contamination

Preventing Cross-Contamination

by Susanne Sailer


read more ...
17.09.2014 |

LOGFILE No. 08/2014 - Packaging Medicinal Products

LOGFILE No. 08/2014 - Packaging Medicinal Products

Packaging Medicinal Products

An excerpt from the GMP MANUAL

by Dr. Christian Gausepohl, Ruven Brandes


read more ...
20.08.2014 |

LOGFILE No. 26/2014 - Principles of Human Resource Management

LOGFILE No. 26/2014 - Principles of Human Resource Management

Principles of human resource management

An excerpt from the GMP MANUAL

by Dr. Michael Hiob


read more ...
19.08.2014 |

LOGFILE No. 07/2014 - How to Master Crisis Situations

LOGFILE No. 07/2014 - How to Master Crisis Situations

How to Master Crisis Situations

by Susanne Sailer


read more ...
19.08.2014 |

LOGFILE No. 05/2014 - Transportation Risk Management

LOGFILE No. 05/2014 - Transportation Risk Management

Risk management in transportation

An excerpt from the GMP MANUAL

by Dr. Nicola Spiggelkötter, Consultant, Germany


read more ...
19.08.2014 |

LOGFILE No. 04/2014 - Key to success in a world of failures

LOGFILE No. 04/2014 - Key to success in a world of failures

Investigation: A Key to Success in a World of Failures

by Thomas Peither, Maas & Peither AG, GMP Publishing, Germany


read more ...
15.08.2014 |

LOGFILE No. 03/2014 - GDP Audit Checklist - GMP News: GDP in India

LOGFILE No. 03/2014 - GDP Audit Checklist - GMP News: GDP in India

Warehousing

An excerpt from the GDP Audit Checklist


read more ...
28.07.2014 |

LOGFILE No. 02/2014 - Fight against counterfeit medicines - GMP News: CFDA

LOGFILE No. 02/2014 - Fight against counterfeit medicines - GMP News: CFDA

Fight against counterfeit medicines

An excerpt from the GMP MANUAL

by Dr. Stephan Schwarze - Bayer Pharma AG, Germany


read more ...
17.07.2014 |

LOGFILE No. 01/2014 - GMP Guidelines: What to expect 2014? - GMP News

LOGFILE No. 01/2014 - GMP Guidelines: What to expect 2014? - GMP News

GMP Guidelines: What to expect 2014?

by Anita Maas and Thomas Peither


read more ...
14.07.2014 |

LOGFILE No. 32/2013 - Risk Assessment for Computerized Systems - GMP News

LOGFILE No. 32/2013 - Risk Assessment for Computerized Systems - GMP News

Risk Management for Computerized Systems

An Excerpt from "Computer System Validation in the EU"


read more ...
07.07.2014 |

LOGFILE No. 31/2013 - Preparing GMP Inspections - Change in EU GDP Guideline

LOGFILE No. 31/2013 - Preparing GMP Inspections - Change in EU GDP Guideline

Preparing GMP Inspections

An Excerpt from "Preparing for the EU GMP Inspection"


read more ...
30.06.2014 |

LOGFILE No. 28/2013 - Process Validation Trends - GMP News

LOGFILE No. 28/2013 - Process Validation Trends - GMP News

Process Validation Trends

By Susanne Sailer

 


read more ...
23.06.2014 |

LOGFILE No. 27/2013 - Industry Perspective on Quality Agreements - GMP News

LOGFILE No. 27/2013 - Industry Perspective on Quality Agreements - GMP News

Quality Agreements: How to build a relationship? (Part II)

By Thomas Peither


read more ...
16.06.2014 |

LOGFILE No. 26/2013 - Quality Risk Management - GMP News

LOGFILE No. 26/2013 - Quality Risk Management - GMP News

There's More to Risk Management than Just Risk Analysis

by Susanne Sailer


read more ...
02.06.2014 |

LOGFILE No. 25/2013 - Excipients - Surprise FDA inspections in India

LOGFILE No. 25/2013 - Excipients - Surprise FDA inspections in India

Excipients - Safety, toxicological, and precedence of use issues

by Iain Moore, Ph. D


read more ...
26.05.2014 |

LOGFILE No. 24/2013 - Outsourcing - Quality Agreements - GMP News

LOGFILE No. 24/2013 - Outsourcing - Quality Agreements - GMP News

Quality Agreements: How to build a relationship? (Part I)

By Thomas Peither


read more ...
19.05.2014 |

LOGFILE No. 23/2013 - GMP Audit Checklist

LOGFILE No. 23/2013 - GMP Audit Checklist

Buildings and Infrastuctrue

an excerpt from the GMP Audit Checklist


read more ...
12.05.2014 |

LOGFILE No. 22/2013 - PDA/FDA Joint Conference

LOGFILE No. 22/2013 - PDA/FDA Joint Conference

What is the Future Interpretation of GMPs?

By Thomas Peither


read more ...
05.05.2014 |

LOGFILE No. 21/2013 - Transport of Medicinal Products

LOGFILE No. 21/2013 - Transport of Medicinal Products

By Dr. Christoph Frick and Dr. Nicola Spiggelkötter

 


read more ...
25.04.2014 |

LOGFILE No. 20/2013 - Change Control

LOGFILE No. 20/2013 - Change Control

Author: Dr. Michael Hiob

 


read more ...
22.04.2014 |

LOGFILE No. 18/2013 - Audit Procedures

LOGFILE No. 18/2013 - Audit Procedures

Authors: Dr. Michael Hiob, Max Lazar


read more ...
14.04.2014 |

LOGFILE No. 17/2013 - Process Validation

LOGFILE No. 17/2013 - Process Validation

Process Validation

PDA Technical Report No. 60 as a practical guideline

By Thomas Peither

 


read more ...
08.04.2014 |

LOGFILE No. 15/2013 - Drugmakers and Contractors

LOGFILE No. 15/2013 - Drugmakers and Contractors

Relation between Drugmaker and Contractor

Extract from “Managing Contract Manufacturers and Testing Labs


read more ...
21.03.2014 |

LOGFILE No. 12/2013 - The Brazilian GMP Guideline

LOGFILE No. 12/2013 - The Brazilian GMP Guideline

The Brazilian GMP Guideline

By Dr. Hans H. Schicht


read more ...
17.03.2014 |

LOGFILE No. 10/2013 - Deviations - GMPnews FDA, India and EU

LOGFILE No. 10/2013 - Deviations - GMPnews FDA, India and EU

Deviations – Definition and Requirements

By Dr. Christian Gausepohl


read more ...
06.03.2014 |

LOGFILE No. 7/2013 - GMP-relevant Documents

LOGFILE No. 7/2013 - GMP-relevant Documents

GMP-relevant Documents

By Dr. Michael Hiob

 


read more ...
27.02.2014 |

LOGFILE No. 5/2013 - Coding and Serialisation

LOGFILE No. 5/2013 - Coding and Serialisation

Coding and Serialisation of Folding Cardboard Boxes in the Pharmaceutical Industry

By Roland Kleissendorf


read more ...
18.02.2014 |

LOGFILE No. 4/2013 - EU GMP Guidelines 2013

LOGFILE No. 4/2013 - EU GMP Guidelines 2013

Which European Guidelines will change in 2013?

By Thomas Peither, Maas & Peither AG - GMP Publishing


read more ...
11.02.2014 |

LOGFILE No. 3/2013 - Improve Quality Systems - Part II

LOGFILE No. 3/2013 - Improve Quality Systems - Part II

Simplification Can Improve Quality Systems, Experts Say Part II

Rebecca Stauffer, PDA


read more ...
27.01.2014 |

LOGFILE No. 2/2013 - Improve Quality Systems

LOGFILE No. 2/2013 - Improve Quality Systems

Simplification Can Improve Quality Systems, Experts Say Part I

Rebecca Stauffer, PDA


read more ...
21.01.2014 |

LOGFILE No. 33/2012 - Biological Active Substances

LOGFILE No. 33/2012 - Biological Active Substances

Comparison of Different Versions of Annex 2 EU Guide to GMP Part I

Maas & Peither AG - GMP Publishing (November 2012)


read more ...
15.01.2014 |

LOGFILE No. 32/2012 - Change Management

LOGFILE No. 32/2012 - Change Management

Principles of Change Control

Author: Michael Hiob, Ph.D., Germany


read more ...
10.12.2013 |

LOGFILE No. 28/2012 - Pharmaceutical Quality System (EU-GMP Chapter 1)

LOGFILE No. 28/2012 - Pharmaceutical Quality System (EU-GMP Chapter 1)

Comparison of Different Versions of Chapter 1 EU Guide to GMP Part I


read more ...
02.12.2013 |

LOGFILE No. 27/2012 - Europe: New "Outsourced Activities"

LOGFILE No. 27/2012 - Europe: New "Outsourced Activities"

Synopsis of Chapter 7 of the EU Guide to GMP

(September 2012)


read more ...
26.11.2013 |

LOGFILE No. 26/2012 - Good Distribution Practice (GDP)

LOGFILE No. 26/2012 - Good Distribution Practice (GDP)

Good Distribution Practice - Current Regulations

Author: Thomas Peither, Maas & Peither AG, GMP Publishing


read more ...
19.11.2013 |

LOGFILE No. 25/2012 - Typical GMP Audit Questions

LOGFILE No. 25/2012 - Typical GMP Audit Questions

10 typical GMP audit questions about electronic records


read more ...
04.11.2013 |

LOGFILE No. 22/2012 - Contract Manufacturer Agreement

LOGFILE No. 22/2012 - Contract Manufacturer Agreement

LOGFILE No. 22/2012 - Contract Manufacturer Agreement

Author: Max Lazar


read more ...
04.11.2013 |

LOGFILE No. 21/2012 - Laboratory Controls - GMP Audit Questions

LOGFILE No. 21/2012 - Laboratory Controls - GMP Audit Questions

Typical Audit Questions: Laboratory Controls


read more ...
28.10.2013 |

LOGFILE No. 20/2012 - Top 10 GMP Deficiencies

LOGFILE No. 20/2012 - Top 10 GMP Deficiencies

The Top 10 GMP Deficiencies of PIC/S Members

Author: Thomas Peither
Maas & Peither GMP Publishing, Germany, USA


read more ...
22.10.2013 |

LOGFILE No. 19/2012 - Site Master File (SMF)

LOGFILE No. 19/2012 - Site Master File (SMF)

Site Master File – Guidelines for structure, contents and extent

Author: Cornelia Wawretschek, GxP Services


read more ...
15.10.2013 |

LOGFILE No. 18/2012 - GMP and Personalized Medicine

LOGFILE No. 18/2012 - GMP and Personalized Medicine

GMP and Personalized Medicine

Author: Thomas Peither, Maas & Peither AG


read more ...
08.10.2013 |

LOGFILE No. 17/2012 - Transfer of qualification activities to suppliers

LOGFILE No. 17/2012 - Transfer of qualification activities to suppliers

Outsourcing qualification activities to suppliers

Authors: Ulrike Reuter, Germany; Max Lazar, USA


read more ...
30.09.2013 |

LOGFILE No. 16/2012 - Computer System Validation

LOGFILE No. 16/2012 - Computer System Validation

The “V model”

Author: Markus Roemer


read more ...
23.09.2013 |

LOGFILE No. 15/2012 - GMP Risk Analysis RA 2x5

LOGFILE No. 15/2012 - GMP Risk Analysis RA 2x5

Risk Analysis RA2x5

Author: Thomas Peither


read more ...
17.09.2013 |

LOGFILE No. 14/2012 - EMA Draft for Process Validation

LOGFILE No. 14/2012 - EMA Draft for Process Validation

EMA Draft for Process Validation

Author: Thomas Peither


read more ...
29.08.2013 |

LOGFILE No. 13/2012 - Commenting on USP Standards

LOGFILE No. 13/2012 - Commenting on USP Standards

The Importance of Commenting on Public Standards

Authors: Sue Schniepp, OSO Biopharmaceutical and Janeen Skutnik-Wilkinson, Pfizer


read more ...
27.08.2013 |

LOGFILE No. 12/2012 - Qualification of Personnel

LOGFILE No. 12/2012 - Qualification of Personnel

Aseptic Processing: Qualification of personnel

Author: Dipl.-Ing. (FH) Ruven Brandes, WDT eG, Germany


read more ...
07.08.2013 |

LOGFILE No. 11/2012 - GDPs for Excipients

LOGFILE No. 11/2012 - GDPs for Excipients

USP and IPEC-Europe Weigh in on GDPs for Excipients

An article by IPQ Publications


read more ...
24.07.2013 |

LOGFILE No. 09/2012 - Quality by Design (QdB)

LOGFILE No. 09/2012 - Quality by Design (QdB)

The New Quality Paradigm

Author: Dr. Siegfried Schmitt


read more ...
17.07.2013 |

LOGFILE No. 07/2012 - GMP Inspection of suppliers

LOGFILE No. 07/2012 - GMP Inspection of suppliers

Inspection of suppliers

Authors: Dr. Michael Hiob, Max Lazar


read more ...
01.07.2013 |

LOGFILE No. 06/2012 - Monitoring of HVAC systems

LOGFILE No. 06/2012 - Monitoring of HVAC systems

Monitoring of HVAC Systems

  • Objectives of process monitoring

  • Data management stipulations

  • Air cleanliness and other room air data

Author: Dr. Hans Schicht


read more ...
26.06.2013 |

LOGFILE No. 04/2012 - GMP Guidelines 2012

LOGFILE No. 04/2012 - GMP Guidelines 2012

GMP-Guidelines: What can we expect in 2012?

Author: Anita Maas, Maas & Peither AG


read more ...
11.06.2013 | LOGFILE Feature No. 03/2012

LOGFILE No. 03/2012 - Process Validation

LOGFILE No. 03/2012 - Process Validation

Process validation from the viewpoint of the FDA

Authors: Dr. Christine Oechslein, GMP Instructor, Germany and Max S. Lazar, FDA Regulatory Compliance Consulting, USA


read more ...
28.05.2013 |

LOGFILE No. 1/2012 - January 2012

LOGFILE No. 1/2012 - January 2012

Contract Manufacture: Duties of the Contract Giver

from Max S. Lazar