GMP:Blog

 

Here you find current and comprehensive information about Good Manufacturing Practice. Whether mobile phone, tablet or laptop - with the GMP:Blog you stay up to date no matter where you are!

Read the information that is important to you!

This is how it works: Use the drop-down fields to filter the information type, your subject area and the year of publication. You would like to decide even faster which type of information to be displayed to you? Then simply click on the graphics!


Filter Articles: 
16.04.2024 | LOGFILE Feature 8/2024

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1

7 min. reading time | by Birte Scharf, PhD

What are advanced therapy medicinal products (ATMPs)?

Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.


read more ...
09.04.2024 | LOGFILE Feature 7/2024

30 Years of GMP - A Personal View on Good Manufacturing Practices

10 min. reading time | by Thomas Peither

When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.


read more ...
19.03.2024 | LOGFILE Feature 6/2024

Sources of Contamination: Rooms and Facilities

6 min. reading time |  by Thomas Peither

Ensuring a clean production environment – sounds simple enough.However, in the pharmaceutical context, cleanliness and contamination are clearly defined, delineated and, of course, regulated, particularly in the manufacture of active ingredients and medicinal products.


read more ...
05.03.2024 | LOGFILE Feature 5/2024

Tests in the New Ph. Eur. Monograph on Cannabis Flower

5 min. reading time | by Sabine Paris

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.


read more ...
23.01.2024 | LOGFILE Feature 2/2024

Can GMP Data be in the Cloud?

7 min. reading time | by Thomas Peither

What is cloud computing?

Cloud computing is not a new technology, but a new way of providing resources for data processing.


read more ...
12.12.2023 | LOGFILE Feature 47/2023

How can the Life Cycle Approach be Applied to Cleaning Validation?

5 min. reading time | by Thomas Peither

The life cycle approach to cleaning validation simply means that control of cleaning effectiveness must be maintained on an ongoing basis.


read more ...
28.11.2023 | LOGFILE Feature 45/2023

GMP Question of the Week: Top 15 in 2023

5 min. reading time | by GMP-Verlag Peither AG

Every week we publish interesting questions and answers about GMP in our column GMP Question of the Week. Today we have compiled the most clicked questions of this year (as of November 2023).

Browse the Top 15 and refresh your knowledge!

Detailed information on each topic can be found in the GMP Compliance Adviser, the world's largest reference work on quality management in the pharmaceutical industry.


read more ...
14.11.2023 | LOGFILE Feature 43/2023

Nothing lasts Forever: Stability Tests are Indispensable

7 min. reading time | by Thomas Peither

The stability of a medicinal product or an active substance is defined as the maintenance of certain quality characteristics (specification) over a fixed period of time under defined conditions.


read more ...
31.10.2023 | LOGFILE Feature 41/2023

Personnel Hygiene is not a Delicate Matter! – What are Hygiene Programmes for?

‘Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.‘ This is explicitly stated in the EU GMP Directive 2017/1572.


read more ...
18.10.2023 | LOGFILE Feature 39/2023

Organisation of Quality Assurance

5 min. reading time | by Thomas Peither

When we take a drug, we first and foremost want it to work – to cure an illness or at least alleviate its symptoms.


read more ...
04.10.2023 | LOGFILE Feature 37/2023

The New ICH Q9 Guideline: The Next Generation of Quality Management

7 min. reading time | by Thomas Peither

 

Subjectivity in QRM should be addressed in every organisation. I had the opportunity to attend a very stimulating presentation by Alex Viehmann, Division Director at OPQ, CDER, U.S. FDA, who shared insights into the new ICH Q9 Guideline on Quality Risk Management (QRM) at the PDA/FDA Joint Regulatory Conference 2023, 18-20 September in Washington.


read more ...
26.09.2023 | LOGFILE Feature 36/2023

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

13 min. reading time | by Christian Gausepohl, PhD

 

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. Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.


read more ...
12.09.2023 | LOGFILE Feature 34/2023

Monitoring of Parameters and Water Quality

The monitoring of critical parameters is largely automated and is part of the plant control system. In the event of a critical system alarm (e.g. TOC outside of tolerance limits), the control system also performs the system shutdown or the transition to a safe operation mode.


read more ...
29.08.2023 | LOGFILE Feature 32/2023

Contamination Control – Cleanliness Zone Concepts

4 min. reading time | by Harald Flechl

 

According to the new Annex 1, a Contamination Control Strategy (CCS) must be implemented for the entire cleanroom and controlled environment system of the facility.


read more ...
01.08.2023 | LOGFILE Feature 30/2023

When travelling...

3 min. reading time | GMP-Verlag

 

Gastrointestinal medicines, headache tablets and perhaps a gel to soothe insect bites? It's no big hassle to pack these and yet they give you a reassuring feeling of security.


read more ...
25.07.2023 | LOGFILE Feature 29/2023

Basis of Cleaning Validation: Setting of PDE Limits

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

 

Cleaning Validation


One of the basic principles of a cleaning validation is the setting of limits for possible cross-contaminants in the subsequent product.


read more ...
11.07.2023 | LOGFILE Feature 27/2023

GMP/GDP Requirements for Different Storage Areas

8 min. reading time | by Thomas Peither

 

General requirements

Adequate size and lighting of all areas where medicinal products, starting materials and packaging materials are stored is essential for the proper performance of operations.


read more ...
04.07.2023 | LOGFILE Feature 26/2023

Regulatory Requirements for Computerised Systems

5 min. reading time | by Dennis Sandkühler, PhD

 

Fundamentally, the use of computerised systems in GxP environments requires a consideration of regulatory requirements.


read more ...
27.06.2023 | LOGFILE Feature 25/2023

Air Handling Systems: GMP Compliant Monitoring and Energy-Saving Operation

8 min. reading time | by Thomas Peither

 

Standards and Data Types

The following standards can be used as a basis for cleanroom monitoring plans:


read more ...
13.06.2023 | LOGFILE Feature 23/2023

New in Annex 1: the Contamination Control Strategy (CCS)

5 min. reading time | by Christoph Brewi and Florian Sieder, PhD

What is meant by CCS?

The current Annex 1 (version of 22/08/2022) of the EU GMP Guide marks a paradigm shift in the rules and regulations of Good Manufacturing Practice (GMP).


read more ...
30.05.2023 | LOGFILE Feature 21/2023

Reference Standards in the Pharmaceutical Laboratory: Procurement and Characterisation

5 min. reading time | by Stephanie Blum

Reference standards

Pharmacopoeial standards are obtained by the chemicals officer from the issuing body and do not require further characterisation before use.


read more ...
16.05.2023 | LOGFILE Feature 19/2023

Biotechnological Medicinal Products: Global Trends and Perspectives

5 min. reading time | by Sabine Paris

The Swiss Biotech Day 2023 took place on 24 and 25 April in Basel. The conference is one of the industry's most important meeting places for developers and manufacturers of biopharmaceuticals and is growing in popularity every year.


read more ...
02.05.2023 | LOGFILE Feature 17/2023

GMP Compliant Plant Qualification: Software Quality Plan

10 min. reading time | by Petra Berlemann

 

A software quality plan – what is it and how do you create such a document?


read more ...
18.04.2023 | LOGFILE Feature 15/2023

greenGMP Supports the Sustainability Goals in the Company

7 min. reading time | by Thomas Peither

You know the sustainability goals in your company, such as achieving CO2 neutrality by 2030 or 2050. But what does that have to do with GMP?


read more ...
11.04.2023 | LOGFILE Feature 14/2023

Regulatory and Industrial Standards for the Qualification of Premises and Air Handling Technology

9 min. reading time | by Harald Flechl

 

 


read more ...
28.03.2023 | LOGFILE Feature 12/2023

Change Control at the Wholesaler or Logistics Provider: Assessment of GxP Relevance

7 min. reading time | by Simone Ferrante

 

Assessment of GxP relevance

Every upcoming change must be checked for GxP-relevance by the responsible person for GDP.


read more ...
14.03.2023 | LOGFILE Feature 10/2023

Qualification of Water Supply Systems – Introduction

4 min. reading time | by Fritz Röder

Pharmaceutical water systems are used for a number of different applications by pharmaceutical manufacturers. These include, for example, the cleaning of various pieces of equipment, the generation of pure steam and the use of water as an ingredient for solid, semi-solid and liquid medicinal products.


read more ...
28.02.2023 | LOGFILE Feature 8/2023

Document and Evaluate GMP Audit Information and Findings

7 min reading time | by Stephanie Blum, PhD

In the course of an audit, the auditors collect the information necessary to achieve the audit objectives on a sample basis, e.g. by inspecting premises, observing operations, interviewing personnel and examining documents and records. Interviews may be conducted at any time during the audit, including during the walkthrough and review of documentation.


read more ...
14.02.2023 | LOGFILE Feature 6/2023

Deviations Happen because People Make Mistakes...

8 min. reading time | by Thomas Peither

In this feature we take look at the ‘black sheep’ of pharmaceutical production. As cute and charming as they may be in the animal world, in the world of GMP they can be rather disturbing.


read more ...
24.01.2023 | LOGFILE Feature 3/2023

7 Questionnaire Blocks for PLC User Requirements

9 min. reading time | by Petra Berlemann and Thomas Peither

 

User Requirements, User Requirements Specification (URS), Specification Sheet

What is it? How do you create such documents? Is it all the same? Or is it something completely different?


read more ...
10.01.2023 | LOGFILE Feature 1/2023

How to Maintain the Qualification Status of Your Equipment

9 min. reading time | GMP-Verlag

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned.


read more ...
13.12.2022 | LOGFILE Feature 47/2022

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

13 Min. reading time | by Doris Borchert, PhD, and Christian Gausepohl, PhD

 

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.Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.


read more ...
29.11.2022 | LOGFILE Feature 45/2022

GMP is not ISO 9001 – Where are the Similarities and Differences?

7 min. reading time | by Thomas Peither

 

Standards such as those in the DIN EN ISO series are not laws, so ISO standards differ quite fundamentally from legally binding regulations. Good Manufacturing Practice (GMP), on the other hand, is laid down in laws, regulations and guidelines.


read more ...
15.11.2022 | LOGFILE Feature 43/2022

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.


read more ...
01.11.2022 | LOGFILE Feature 41/2022

Basis of Cleaning Validation: Setting of PDE Limits

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

 

Cleaning Validation


read more ...
18.10.2022 | LOGFILE Feature 39/2022

4 Questions on the Import of Medicinal Products and APIs

6 min. reading time | by Simone Ferrante

 

GMP or GDP – Which applies for importation?

Although the import of medicinal products is an act related to dis-tribution and logistics, this activity is considered GMP relevant in the EU and is therefore subject to GMP requirements.


read more ...
30.08.2022 | LOGFILE Feature 32/2022

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems

8 min. reading time | by Richard Denk

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.


read more ...
09.08.2022 | LOGFILE Leitartikel 31/2022

Why is it Necessary to “Manage“ Quality?

6 min. reading time | by Christine Oechslein, PhD

The quality of a medicinal product cannot be left to chance, but must be the result of carefully planned actions. The sequence "planning, acting, evaluating, improving" is referred to as "management".


read more ...
26.07.2022 | LOGFILE Feature 29/2022

Reaching the next GMP Level with Inspection Readiness Projects

9 min. reading time | by Frank Studt and Thomas Peither


read more ...
19.07.2022 | LOGFILE Leitartikel 28/2022

Mit Inspection-Readiness-Projekten das nächste GMP-Level erreichen

9 Min. Lesezeit | Auszug aus dem Interview mit Frank Studt, Managing Director gempex GmbH, und Thomas Peither beim GMP:talk auf den LOUNGES 2022


read more ...
12.07.2022 | LOGFILE Feature 27/2022

Definition of Hygiene Zones

7 min. reading time | by Christine Oechslein, PhD


read more ...
14.06.2022 | LOGFILE Feature 23/2022

How is process validation differentiated from other elements of quality management?

8 min. reading time | by Thomas Peither

 

The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.


read more ...
31.05.2022 | LOGFILE Feature 21/2022

Import of Medicinal Products – Clarifications in Annex 21

10 min. reading time | by Sabine Paris, PhD

 

The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).


read more ...
17.05.2022 | LOGFILE Feature 19/2022

Initial Classification of a Commercial Return (CR) by the CR Coordinator

7 min. reading time | by Alexandra Fürst

 


read more ...
03.05.2022 | LOGFILE Feature 17/2022

CAPA Systems: Autonomous or Integrated?

8 min. reading time | by Thomas Peither

 

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.


read more ...
19.04.2022 | LOGFILE Feature 15/2022

Risk Analysis in the Equipment Life Cycle

5 min. reading time |

 

From the start of the project to the release of the technical design: Risk analysis is a constant companion.
Risk analyses can or must be carried out at different points in time within the process of procurement and qualification. Here is a brief outline of the phases of risk analyses in project implementation.


read more ...
05.04.2022 | LOGFILE Features 13/2022

13 GMP Requirements for Excipient Manufacturers

7 min. reading time | by Stephanie Blum, PhD

 

Based on the risk assessment documented in the excipient dossier and the risk profile of the excipient, the risk team defines the necessary GMP requirements in the next step.


read more ...
22.03.2022 | LOGFILE Feature 11/2022

Deviation Causes as KPIs – Collection vs. Assessment

7 min. reading time | by Felix Kern, PhD and Liwa Schneider

 

Deviation management plays an increasingly important role in the collection and review of KPIs (Key Performance Indicators) for pharmaceutical production and quality processes. Tracking the cause of deviations in particular provides information on how stable the respective processes are, where there are gaps and where countermeasures need to be taken with corrective and preventive actions (CAPAs).


read more ...
08.03.2022 | LOGFILE Feature 09/2022

Comparison of cleaning processes

7 min. reading time | by Torsten Knöpke


read more ...
22.02.2022 | LOGFILE Feature 07/2022

Nitrosamines: Authorities‘ Expectations and Typical Mistakes

8 min. reading time | by Sabine Paris, PhD

 

"Contaminants in medicinal products – focus on nitrosamines" was the title of an online training course organised by the German FORUM Institute on 12 November 2021. Four renowned experts from the authorities, industry and consulting shed light on all aspects of nitrosamines that play a role in the life cycle of a medicinal product:


read more ...
08.02.2022 | LOGFILE Feature 05/2022

9 Check Points for the Incoming Goods Protocol at the Logistician's or Wholesaler's Premises

8 min. reading time | by Simone Ferrante

 

Receipt of medicinal products

When materials or products are delivered, their quality is assessed. Therefore, this work step should be carried out by experienced and particularly reliable employees.


read more ...
24.01.2022 | LOGFILE Feature 03/2022

Update on Annex 1 of the EU GMP Guide

7 min. reading time | by Doris Borchert, PhD

 

The 27th PTS GMP Conference took place face-to-face and in parallel digitally from 30.11. to 01.12.2021 in Mainz, Germany. The hybrid event was broadcast live from the Atrium Hotel in Mainz, where most of the speakers were present in person.

The presentation by Rico Schulze, Saxon State Ministry for Social Affairs and Social Cohesion, on the revision status and publication of Annex 1 to the EU GMP Guideline was particularly eagerly awaited.


read more ...
18.01.2022 | LOGFILE Feature 02/2022

The GMP Regulations Report 2021

13 min. reading time | shortened version

 

From a regulatory perspective, the year 2021 had plenty in store. Parallel to the omnipresent COVID-19 pandemic, the authorities around the world managed to finalize draft documents that became “sideshows” while the pandemic took centre stage. What topics kept the GMP professionals on their toes?


read more ...
11.01.2022 | LOGFILE Feature 01/2022

How to Maintain the Qualification Status of Your Equipment

8 min. reading time | GMP-Verlag

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned. This is ensured by regular calibration, maintenance, effective change management and periodic review.


read more ...
14.12.2021 | LOGFILE Feature 47/2021

Original Data and True Copies

6 min. reading time | by Christine Oechslein, PhD, and Cornelia Wawretschek

 

For almost all purposes in the GMP sector, it is mandatory to use original data and documents or only true copies thereof. This requirement also forms part of the ALCOA principle. Since it is only possible in a few cases in operational practice to work with the sole original document, the question arises as to what requirements are to be placed on the requisite true copies (see definition in Figure 15.B-6). Figure 15.B-7 compares different types of copies with the concept of original data.


read more ...
07.12.2021 | LOGFILE Feature 46/2021

Supplier Qualification: Pre-Selection Process

7 min. reading time | by Stephanie Blum, PhD

 

If a new service or material is required, the competent department first checks whether this service or material can be obtained from an already qualified supplier. If this is the case, the department initiates a follow-up qualification. Otherwise, the identification and pre-selection of potential new suppliers is carried out by the department itself.


read more ...
30.11.2021 | LOGFILE Feature 45/2021

Process Models for the Validation of Excel Applications

8 min. reading time | by Thomas Trantow, PhD

 

Definition of the types of Excel applications


read more ...
23.11.2021 | LOGFILE Feature 44/2021

Responsible Person according to GDP at the Logistics Service Provider

8 min. reading time | by Simone Ferrante

 

In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.


read more ...
16.11.2021 | LOGFILE Feature 43/2021

Cleanrooms: The Path from Concept to Qualified System

6 min. reading time | by Harald Flechl

 

Good Engineering Practice (GEP) for procurement

Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:


read more ...
09.11.2021 | LOGFILE Feature 42/2021

Smart Deviation Management – Vision or Reality?

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

 

The GMP-compliant and timely management of deviations is very often addressed in audits. One reason for this is that deviations reveal gaps in the defined quality systems or indicate that they have not been set up correctly.


read more ...
02.11.2021 | LOGFILE Feature 41/2021

Typical GMP Deficiencies at Manufacturers of Chemical APIs - An Overview

7 min. reading time | by Norbert Waldöfner, PhD

 

Figure 20.F-24 provides an overview of the GMP deficiencies that, in the author's experience, are frequently encountered during audits of active substance manufacturers.


read more ...
26.10.2021 | LOGFILE Feature 40/2021

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.


read more ...
19.10.2021 | LOGFILE Feature 39/2021

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.


read more ...
12.10.2021 | LOGFILE Feature 38/2021

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.


read more ...
05.10.2021 | LOGFILE Feature 37/2021

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.


read more ...
28.09.2021 | LOGFILE Feature 36/2021

Basis of Cleaning Validation: Setting of PDE Limits

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


read more ...
21.09.2021 | LOGFILE Feature 35/2021

Process Development as the Basis for Process Validation

7 min. reading time | by GMP-Verlag

 

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.


read more ...
14.09.2021 | LOGFILE Feature 34/2021

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.


read more ...
07.09.2021 | LOGFILE Feature 33/2021

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.

 


read more ...
31.08.2021 | LOGFILE Feature 32/2021

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.


read more ...
24.08.2021 | LOGFILE Feature 31/2021

Remote, Distance, Offsite or Virtual Audits?

12 min. reading time | by Thomas Peither


read more ...
03.08.2021 | LOGFILE Feature 30/2021

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.


read more ...
27.07.2021 | LOGFILE Feature 29/2021

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.


read more ...
20.07.2021 | LOGFILE Feature 28/2021

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.


read more ...
14.07.2021 | LOGFILE Feature 27/2021

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.


read more ...
06.07.2021 | LOGFILE Feature 26/2021

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.


read more ...
29.06.2021 | LOGFILE Feature 25/2021

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:


read more ...
22.06.2021 | LOGFILE Feature 24/2021

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)!


read more ...
15.06.2021 | LOGFILE Feature 23/2021

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.


read more ...
08.06.2021 | LOGFILE Feature 22/2021

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.


read more ...
01.06.2021 | LOGFILE Feature 21/2021

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.


read more ...
25.05.2021 | LOGFILE Feature 20/2021

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:


read more ...
18.05.2021 | LOGFILE Feature 19/2021

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.


read more ...
11.05.2021 | LOGFILE Feature 18/2021

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?


read more ...
04.05.2021 | LOGFILE Feature 17/2021

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).


read more ...
27.04.2021 | LOGFILE Feature 18/2021

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.


read more ...
20.04.2021 | LOGFILE Feature 15/2021

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.


read more ...
13.04.2021 | LOGFILE Feature 13/2021

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.


read more ...
06.04.2021 | LOGFILE Feature 13/2021

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.


read more ...
30.03.2021 | LOGFILE Feature 12/2021

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.


read more ...
23.03.2021 | LOGFILE Feature 11/2021

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.


read more ...
16.03.2021 | LOGFILE Feature 10/2021

Rouging When Stainless Steel Corrodes

12 min. reading time | by Herbert Bendlin

 

What is rouging?


read more ...
09.03.2021 | LOGFILE Feature 09/2021

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.


read more ...
02.03.2021 | LOGFILE Feature 08/2021

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.


read more ...
23.02.2021 | LOGFILE Feature 07/2021

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.


read more ...
16.02.2021 | LOGFILE Feature 06/2021

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.


read more ...
09.02.2021 | LOGFILE Feature 05/2021

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:


read more ...
02.02.2021 | LOGFILE Feature 04/2021

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.


read more ...
26.01.2021 | LOGFILE Feature 03/2021

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.


read more ...
19.01.2021 | LOGFILE Feature 02/2021

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.


read more ...
04.01.2021 | LOGFILE Feature 01/2021

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.


read more ...
15.12.2020 | LOGFILE Feature 48/2020

Online packaging line controls

6 min. reading time | by Vera Werner


read more ...
08.12.2020 | LOGFILE Feature 47/2020

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.


read more ...
01.12.2020 | LOGFILE Feature 46/2020

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


read more ...
24.11.2020 | LOGFILE Feature 45/2020

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.


read more ...
17.11.2020 | LOGFILE Feature 44/2020

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?


read more ...
10.11.2020 | LOGFILE Feature 43/2020

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.


read more ...
03.11.2020 | LOGFILE Feature 42/2020

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.


read more ...
27.10.2020 | LOGFILE Feature 41/2020

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.


read more ...
20.10.2020 | LOGFILE Feature 40/2020

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.


read more ...
13.10.2020 | LOGFILE Feature 39/2020

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.


read more ...
06.10.2020 | LOGFILE Feature 38/2020

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 ...
29.09.2020 | LOGFILE Feature 37/2020

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".


read more ...
22.09.2020 | LOGFILE Feature 36/2020

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.


read more ...
16.09.2020 | LOGFILE Feature 35/2020

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.


read more ...
08.09.2020 | LOGFILE Feature 34/2020

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.


read more ...
25.08.2020 | LOGFILE Feature 32/2020

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

8 min. reading time | by Thomas Peither


read more ...
04.08.2020 | LOGFILE Feature 31/2020

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:


read more ...
28.07.2020 | LOGFILE Feature 30/2020

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.


read more ...
21.07.2020 | LOGFILE Feature 29/2020

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?


read more ...
07.07.2020 | LOGFILE Feature 27/2020

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.


read more ...
30.06.2020 | LOGFILE Feature 26/2020

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.


read more ...
23.06.2020 | LOGFILE Feature 25/2020

GMP:READY: GMP for Engineers

5 min. reading time


read more ...
09.06.2020 | LOGFILE Feature 23/2020

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

9 min. reading time | by Grant Courtney


read more ...
02.06.2020 | LOGFILE Feature 22/2020

Environmental Risk Assessment: ERA Reports

8 min. reading time

 

1 Introduction: environmental risk evaluation


read more ...
26.05.2020 | LOGFILE Feature 21/2020

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.


read more ...
19.05.2020 | LOGFILE Feature 20/2020

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


read more ...
12.05.2020 | LOGFILE Feature 19/2020

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?


read more ...
05.05.2020 | LOGFILE Feature 18/2020

Nothing ventured, nothing gained

28.04.2020 | LOGFILE Feature 17/2020

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.


read more ...
21.04.2020 | LOGFILE Feature 16/2020

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.


read more ...
15.04.2020 | LOGFILE Feature 15/2020

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.


read more ...
08.04.2020 | LOGFILE Feature 14/2020

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.


read more ...
01.04.2020 | LOGFILE Feature 13/2020

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?


read more ...
24.03.2020 | LOGFILE Feature 12/2020

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.


read more ...
18.03.2020 | LOGFILE Feature 11/2020

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.


read more ...
10.03.2020 | LOGFILE Feature 10/2020

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.


read more ...
04.03.2020 | LOGFILE Feature 09/2020

The GMP Regulations Report 2019

15 min. reading time | by Sabine Rabus

 

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


read more ...
26.02.2020 | LOGFILE Feature 08/2020

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.


read more ...
18.02.2020 | LOGFILE Feature 07/2020

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].


read more ...
11.02.2020 | LOGFILE Feature 06/2020

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.


read more ...
04.02.2020 | LOGFILE Feature 05/2020

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". 


read more ...
28.01.2020 | LOGFILE Feature 04/2020

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

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

 

Selection and procurement


read more ...
14.01.2020 | LOGFILE Feature 02/2020

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?


read more ...
07.01.2020 | LOGFILE Feature 01/2020

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.


read more ...
16.04.2024 | LOGFILE Feature 8/2024

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1

7 min. reading time | by Birte Scharf, PhD

What are advanced therapy medicinal products (ATMPs)?

Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.


read more ...
19.03.2024 | LOGFILE Feature 6/2024

Sources of Contamination: Rooms and Facilities

6 min. reading time |  by Thomas Peither

Ensuring a clean production environment – sounds simple enough.However, in the pharmaceutical context, cleanliness and contamination are clearly defined, delineated and, of course, regulated, particularly in the manufacture of active ingredients and medicinal products.


read more ...
23.01.2024 | LOGFILE Feature 2/2024

Can GMP Data be in the Cloud?

7 min. reading time | by Thomas Peither

What is cloud computing?

Cloud computing is not a new technology, but a new way of providing resources for data processing.


read more ...
28.11.2023 | LOGFILE Feature 45/2023

GMP Question of the Week: Top 15 in 2023

5 min. reading time | by GMP-Verlag Peither AG

Every week we publish interesting questions and answers about GMP in our column GMP Question of the Week. Today we have compiled the most clicked questions of this year (as of November 2023).

Browse the Top 15 and refresh your knowledge!

Detailed information on each topic can be found in the GMP Compliance Adviser, the world's largest reference work on quality management in the pharmaceutical industry.


read more ...
31.10.2023 | LOGFILE Feature 41/2023

Personnel Hygiene is not a Delicate Matter! – What are Hygiene Programmes for?

‘Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.‘ This is explicitly stated in the EU GMP Directive 2017/1572.


read more ...
04.10.2023 | LOGFILE Feature 37/2023

The New ICH Q9 Guideline: The Next Generation of Quality Management

7 min. reading time | by Thomas Peither

 

Subjectivity in QRM should be addressed in every organisation. I had the opportunity to attend a very stimulating presentation by Alex Viehmann, Division Director at OPQ, CDER, U.S. FDA, who shared insights into the new ICH Q9 Guideline on Quality Risk Management (QRM) at the PDA/FDA Joint Regulatory Conference 2023, 18-20 September in Washington.


read more ...
12.09.2023 | LOGFILE Feature 34/2023

Monitoring of Parameters and Water Quality

The monitoring of critical parameters is largely automated and is part of the plant control system. In the event of a critical system alarm (e.g. TOC outside of tolerance limits), the control system also performs the system shutdown or the transition to a safe operation mode.


read more ...
01.08.2023 | LOGFILE Feature 30/2023

When travelling...

3 min. reading time | GMP-Verlag

 

Gastrointestinal medicines, headache tablets and perhaps a gel to soothe insect bites? It's no big hassle to pack these and yet they give you a reassuring feeling of security.


read more ...
11.07.2023 | LOGFILE Feature 27/2023

GMP/GDP Requirements for Different Storage Areas

8 min. reading time | by Thomas Peither

 

General requirements

Adequate size and lighting of all areas where medicinal products, starting materials and packaging materials are stored is essential for the proper performance of operations.


read more ...
27.06.2023 | LOGFILE Feature 25/2023

Air Handling Systems: GMP Compliant Monitoring and Energy-Saving Operation

8 min. reading time | by Thomas Peither

 

Standards and Data Types

The following standards can be used as a basis for cleanroom monitoring plans:


read more ...
30.05.2023 | LOGFILE Feature 21/2023

Reference Standards in the Pharmaceutical Laboratory: Procurement and Characterisation

5 min. reading time | by Stephanie Blum

Reference standards

Pharmacopoeial standards are obtained by the chemicals officer from the issuing body and do not require further characterisation before use.


read more ...
02.05.2023 | LOGFILE Feature 17/2023

GMP Compliant Plant Qualification: Software Quality Plan

10 min. reading time | by Petra Berlemann

 

A software quality plan – what is it and how do you create such a document?


read more ...
11.04.2023 | LOGFILE Feature 14/2023

Regulatory and Industrial Standards for the Qualification of Premises and Air Handling Technology

9 min. reading time | by Harald Flechl

 

 


read more ...
14.03.2023 | LOGFILE Feature 10/2023

Qualification of Water Supply Systems – Introduction

4 min. reading time | by Fritz Röder

Pharmaceutical water systems are used for a number of different applications by pharmaceutical manufacturers. These include, for example, the cleaning of various pieces of equipment, the generation of pure steam and the use of water as an ingredient for solid, semi-solid and liquid medicinal products.


read more ...
14.02.2023 | LOGFILE Feature 6/2023

Deviations Happen because People Make Mistakes...

8 min. reading time | by Thomas Peither

In this feature we take look at the ‘black sheep’ of pharmaceutical production. As cute and charming as they may be in the animal world, in the world of GMP they can be rather disturbing.


read more ...
10.01.2023 | LOGFILE Feature 1/2023

How to Maintain the Qualification Status of Your Equipment

9 min. reading time | GMP-Verlag

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned.


read more ...
29.11.2022 | LOGFILE Feature 45/2022

GMP is not ISO 9001 – Where are the Similarities and Differences?

7 min. reading time | by Thomas Peither

 

Standards such as those in the DIN EN ISO series are not laws, so ISO standards differ quite fundamentally from legally binding regulations. Good Manufacturing Practice (GMP), on the other hand, is laid down in laws, regulations and guidelines.


read more ...
01.11.2022 | LOGFILE Feature 41/2022

Basis of Cleaning Validation: Setting of PDE Limits

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

 

Cleaning Validation


read more ...
30.08.2022 | LOGFILE Feature 32/2022

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems

8 min. reading time | by Richard Denk

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.


read more ...
26.07.2022 | LOGFILE Feature 29/2022

Reaching the next GMP Level with Inspection Readiness Projects

9 min. reading time | by Frank Studt and Thomas Peither


read more ...
12.07.2022 | LOGFILE Feature 27/2022

Definition of Hygiene Zones

7 min. reading time | by Christine Oechslein, PhD


read more ...
31.05.2022 | LOGFILE Feature 21/2022

Import of Medicinal Products – Clarifications in Annex 21

10 min. reading time | by Sabine Paris, PhD

 

The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).


read more ...
03.05.2022 | LOGFILE Feature 17/2022

CAPA Systems: Autonomous or Integrated?

8 min. reading time | by Thomas Peither

 

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.


read more ...
05.04.2022 | LOGFILE Features 13/2022

13 GMP Requirements for Excipient Manufacturers

7 min. reading time | by Stephanie Blum, PhD

 

Based on the risk assessment documented in the excipient dossier and the risk profile of the excipient, the risk team defines the necessary GMP requirements in the next step.


read more ...
08.03.2022 | LOGFILE Feature 09/2022

Comparison of cleaning processes

7 min. reading time | by Torsten Knöpke


read more ...
08.02.2022 | LOGFILE Feature 05/2022

9 Check Points for the Incoming Goods Protocol at the Logistician's or Wholesaler's Premises

8 min. reading time | by Simone Ferrante

 

Receipt of medicinal products

When materials or products are delivered, their quality is assessed. Therefore, this work step should be carried out by experienced and particularly reliable employees.


read more ...
18.01.2022 | LOGFILE Feature 02/2022

The GMP Regulations Report 2021

13 min. reading time | shortened version

 

From a regulatory perspective, the year 2021 had plenty in store. Parallel to the omnipresent COVID-19 pandemic, the authorities around the world managed to finalize draft documents that became “sideshows” while the pandemic took centre stage. What topics kept the GMP professionals on their toes?


read more ...
14.12.2021 | LOGFILE Feature 47/2021

Original Data and True Copies

6 min. reading time | by Christine Oechslein, PhD, and Cornelia Wawretschek

 

For almost all purposes in the GMP sector, it is mandatory to use original data and documents or only true copies thereof. This requirement also forms part of the ALCOA principle. Since it is only possible in a few cases in operational practice to work with the sole original document, the question arises as to what requirements are to be placed on the requisite true copies (see definition in Figure 15.B-6). Figure 15.B-7 compares different types of copies with the concept of original data.


read more ...
30.11.2021 | LOGFILE Feature 45/2021

Process Models for the Validation of Excel Applications

8 min. reading time | by Thomas Trantow, PhD

 

Definition of the types of Excel applications


read more ...
16.11.2021 | LOGFILE Feature 43/2021

Cleanrooms: The Path from Concept to Qualified System

6 min. reading time | by Harald Flechl

 

Good Engineering Practice (GEP) for procurement

Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:


read more ...
02.11.2021 | LOGFILE Feature 41/2021

Typical GMP Deficiencies at Manufacturers of Chemical APIs - An Overview

7 min. reading time | by Norbert Waldöfner, PhD

 

Figure 20.F-24 provides an overview of the GMP deficiencies that, in the author's experience, are frequently encountered during audits of active substance manufacturers.


read more ...
19.10.2021 | LOGFILE Feature 39/2021

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.


read more ...
05.10.2021 | LOGFILE Feature 37/2021

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.


read more ...
21.09.2021 | LOGFILE Feature 35/2021

Process Development as the Basis for Process Validation

7 min. reading time | by GMP-Verlag

 

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.


read more ...
07.09.2021 | LOGFILE Feature 33/2021

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.

 


read more ...
24.08.2021 | LOGFILE Feature 31/2021

Remote, Distance, Offsite or Virtual Audits?

12 min. reading time | by Thomas Peither


read more ...
27.07.2021 | LOGFILE Feature 29/2021

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.


read more ...
14.07.2021 | LOGFILE Feature 27/2021

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.


read more ...
29.06.2021 | LOGFILE Feature 25/2021

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:


read more ...
15.06.2021 | LOGFILE Feature 23/2021

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.


read more ...
01.06.2021 | LOGFILE Feature 21/2021

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.


read more ...
18.05.2021 | LOGFILE Feature 19/2021

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.


read more ...
04.05.2021 | LOGFILE Feature 17/2021

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).


read more ...
20.04.2021 | LOGFILE Feature 15/2021

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.


read more ...
06.04.2021 | LOGFILE Feature 13/2021

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.


read more ...
23.03.2021 | LOGFILE Feature 11/2021

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.


read more ...
09.03.2021 | LOGFILE Feature 09/2021

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.


read more ...
23.02.2021 | LOGFILE Feature 07/2021

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.


read more ...
09.02.2021 | LOGFILE Feature 05/2021

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:


read more ...
26.01.2021 | LOGFILE Feature 03/2021

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.


read more ...
04.01.2021 | LOGFILE Feature 01/2021

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.


read more ...
08.12.2020 | LOGFILE Feature 47/2020

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.


read more ...
24.11.2020 | LOGFILE Feature 45/2020

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.


read more ...
10.11.2020 | LOGFILE Feature 43/2020

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.


read more ...
27.10.2020 | LOGFILE Feature 41/2020

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.


read more ...
13.10.2020 | LOGFILE Feature 39/2020

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.


read more ...
29.09.2020 | LOGFILE Feature 37/2020

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".


read more ...
16.09.2020 | LOGFILE Feature 35/2020

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.


read more ...
25.08.2020 | LOGFILE Feature 32/2020

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

8 min. reading time | by Thomas Peither


read more ...
28.07.2020 | LOGFILE Feature 30/2020

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.


read more ...
30.06.2020 | LOGFILE Feature 26/2020

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.


read more ...
09.06.2020 | LOGFILE Feature 23/2020

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

9 min. reading time | by Grant Courtney


read more ...
26.05.2020 | LOGFILE Feature 21/2020

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.


read more ...
12.05.2020 | LOGFILE Feature 19/2020

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?


read more ...
28.04.2020 | LOGFILE Feature 17/2020

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.


read more ...
15.04.2020 | LOGFILE Feature 15/2020

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.


read more ...
01.04.2020 | LOGFILE Feature 13/2020

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?


read more ...
18.03.2020 | LOGFILE Feature 11/2020

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.


read more ...
04.03.2020 | LOGFILE Feature 09/2020

The GMP Regulations Report 2019

15 min. reading time | by Sabine Rabus

 

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


read more ...
18.02.2020 | LOGFILE Feature 07/2020

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].


read more ...
04.02.2020 | LOGFILE Feature 05/2020

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". 


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

Selection and procurement of cleanroom construction components

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

 

Selection and procurement


read more ...
07.01.2020 | LOGFILE Feature 01/2020

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.


read more ...
09.04.2024 | LOGFILE Feature 7/2024

30 Years of GMP - A Personal View on Good Manufacturing Practices

10 min. reading time | by Thomas Peither

When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.


read more ...
05.03.2024 | LOGFILE Feature 5/2024

Tests in the New Ph. Eur. Monograph on Cannabis Flower

5 min. reading time | by Sabine Paris

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.


read more ...
12.12.2023 | LOGFILE Feature 47/2023

How can the Life Cycle Approach be Applied to Cleaning Validation?

5 min. reading time | by Thomas Peither

The life cycle approach to cleaning validation simply means that control of cleaning effectiveness must be maintained on an ongoing basis.


read more ...
14.11.2023 | LOGFILE Feature 43/2023

Nothing lasts Forever: Stability Tests are Indispensable

7 min. reading time | by Thomas Peither

The stability of a medicinal product or an active substance is defined as the maintenance of certain quality characteristics (specification) over a fixed period of time under defined conditions.


read more ...
18.10.2023 | LOGFILE Feature 39/2023

Organisation of Quality Assurance

5 min. reading time | by Thomas Peither

When we take a drug, we first and foremost want it to work – to cure an illness or at least alleviate its symptoms.


read more ...
26.09.2023 | LOGFILE Feature 36/2023

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

13 min. reading time | by Christian Gausepohl, PhD

 

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. Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.


read more ...
29.08.2023 | LOGFILE Feature 32/2023

Contamination Control – Cleanliness Zone Concepts

4 min. reading time | by Harald Flechl

 

According to the new Annex 1, a Contamination Control Strategy (CCS) must be implemented for the entire cleanroom and controlled environment system of the facility.


read more ...
25.07.2023 | LOGFILE Feature 29/2023

Basis of Cleaning Validation: Setting of PDE Limits

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

 

Cleaning Validation


One of the basic principles of a cleaning validation is the setting of limits for possible cross-contaminants in the subsequent product.


read more ...
04.07.2023 | LOGFILE Feature 26/2023

Regulatory Requirements for Computerised Systems

5 min. reading time | by Dennis Sandkühler, PhD

 

Fundamentally, the use of computerised systems in GxP environments requires a consideration of regulatory requirements.


read more ...
13.06.2023 | LOGFILE Feature 23/2023

New in Annex 1: the Contamination Control Strategy (CCS)

5 min. reading time | by Christoph Brewi and Florian Sieder, PhD

What is meant by CCS?

The current Annex 1 (version of 22/08/2022) of the EU GMP Guide marks a paradigm shift in the rules and regulations of Good Manufacturing Practice (GMP).


read more ...
16.05.2023 | LOGFILE Feature 19/2023

Biotechnological Medicinal Products: Global Trends and Perspectives

5 min. reading time | by Sabine Paris

The Swiss Biotech Day 2023 took place on 24 and 25 April in Basel. The conference is one of the industry's most important meeting places for developers and manufacturers of biopharmaceuticals and is growing in popularity every year.


read more ...
18.04.2023 | LOGFILE Feature 15/2023

greenGMP Supports the Sustainability Goals in the Company

7 min. reading time | by Thomas Peither

You know the sustainability goals in your company, such as achieving CO2 neutrality by 2030 or 2050. But what does that have to do with GMP?


read more ...
28.03.2023 | LOGFILE Feature 12/2023

Change Control at the Wholesaler or Logistics Provider: Assessment of GxP Relevance

7 min. reading time | by Simone Ferrante

 

Assessment of GxP relevance

Every upcoming change must be checked for GxP-relevance by the responsible person for GDP.


read more ...
28.02.2023 | LOGFILE Feature 8/2023

Document and Evaluate GMP Audit Information and Findings

7 min reading time | by Stephanie Blum, PhD

In the course of an audit, the auditors collect the information necessary to achieve the audit objectives on a sample basis, e.g. by inspecting premises, observing operations, interviewing personnel and examining documents and records. Interviews may be conducted at any time during the audit, including during the walkthrough and review of documentation.


read more ...
24.01.2023 | LOGFILE Feature 3/2023

7 Questionnaire Blocks for PLC User Requirements

9 min. reading time | by Petra Berlemann and Thomas Peither

 

User Requirements, User Requirements Specification (URS), Specification Sheet

What is it? How do you create such documents? Is it all the same? Or is it something completely different?


read more ...
13.12.2022 | LOGFILE Feature 47/2022

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

13 Min. reading time | by Doris Borchert, PhD, and Christian Gausepohl, PhD

 

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.Everyone has a bad day, is distracted or unfocused, forgets or mixes things up and makes mistakes, even though they "actually" know how to do it correctly.


read more ...
15.11.2022 | LOGFILE Feature 43/2022

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.


read more ...
18.10.2022 | LOGFILE Feature 39/2022

4 Questions on the Import of Medicinal Products and APIs

6 min. reading time | by Simone Ferrante

 

GMP or GDP – Which applies for importation?

Although the import of medicinal products is an act related to dis-tribution and logistics, this activity is considered GMP relevant in the EU and is therefore subject to GMP requirements.


read more ...
09.08.2022 | LOGFILE Leitartikel 31/2022

Why is it Necessary to “Manage“ Quality?

6 min. reading time | by Christine Oechslein, PhD

The quality of a medicinal product cannot be left to chance, but must be the result of carefully planned actions. The sequence "planning, acting, evaluating, improving" is referred to as "management".


read more ...
19.07.2022 | LOGFILE Leitartikel 28/2022

Mit Inspection-Readiness-Projekten das nächste GMP-Level erreichen

9 Min. Lesezeit | Auszug aus dem Interview mit Frank Studt, Managing Director gempex GmbH, und Thomas Peither beim GMP:talk auf den LOUNGES 2022


read more ...
14.06.2022 | LOGFILE Feature 23/2022

How is process validation differentiated from other elements of quality management?

8 min. reading time | by Thomas Peither

 

The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.


read more ...
17.05.2022 | LOGFILE Feature 19/2022

Initial Classification of a Commercial Return (CR) by the CR Coordinator

7 min. reading time | by Alexandra Fürst

 


read more ...
19.04.2022 | LOGFILE Feature 15/2022

Risk Analysis in the Equipment Life Cycle

5 min. reading time |

 

From the start of the project to the release of the technical design: Risk analysis is a constant companion.
Risk analyses can or must be carried out at different points in time within the process of procurement and qualification. Here is a brief outline of the phases of risk analyses in project implementation.


read more ...
22.03.2022 | LOGFILE Feature 11/2022

Deviation Causes as KPIs – Collection vs. Assessment

7 min. reading time | by Felix Kern, PhD and Liwa Schneider

 

Deviation management plays an increasingly important role in the collection and review of KPIs (Key Performance Indicators) for pharmaceutical production and quality processes. Tracking the cause of deviations in particular provides information on how stable the respective processes are, where there are gaps and where countermeasures need to be taken with corrective and preventive actions (CAPAs).


read more ...
22.02.2022 | LOGFILE Feature 07/2022

Nitrosamines: Authorities‘ Expectations and Typical Mistakes

8 min. reading time | by Sabine Paris, PhD

 

"Contaminants in medicinal products – focus on nitrosamines" was the title of an online training course organised by the German FORUM Institute on 12 November 2021. Four renowned experts from the authorities, industry and consulting shed light on all aspects of nitrosamines that play a role in the life cycle of a medicinal product:


read more ...
24.01.2022 | LOGFILE Feature 03/2022

Update on Annex 1 of the EU GMP Guide

7 min. reading time | by Doris Borchert, PhD

 

The 27th PTS GMP Conference took place face-to-face and in parallel digitally from 30.11. to 01.12.2021 in Mainz, Germany. The hybrid event was broadcast live from the Atrium Hotel in Mainz, where most of the speakers were present in person.

The presentation by Rico Schulze, Saxon State Ministry for Social Affairs and Social Cohesion, on the revision status and publication of Annex 1 to the EU GMP Guideline was particularly eagerly awaited.


read more ...
11.01.2022 | LOGFILE Feature 01/2022

How to Maintain the Qualification Status of Your Equipment

8 min. reading time | GMP-Verlag

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned. This is ensured by regular calibration, maintenance, effective change management and periodic review.


read more ...
07.12.2021 | LOGFILE Feature 46/2021

Supplier Qualification: Pre-Selection Process

7 min. reading time | by Stephanie Blum, PhD

 

If a new service or material is required, the competent department first checks whether this service or material can be obtained from an already qualified supplier. If this is the case, the department initiates a follow-up qualification. Otherwise, the identification and pre-selection of potential new suppliers is carried out by the department itself.


read more ...
23.11.2021 | LOGFILE Feature 44/2021

Responsible Person according to GDP at the Logistics Service Provider

8 min. reading time | by Simone Ferrante

 

In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.


read more ...
09.11.2021 | LOGFILE Feature 42/2021

Smart Deviation Management – Vision or Reality?

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

 

The GMP-compliant and timely management of deviations is very often addressed in audits. One reason for this is that deviations reveal gaps in the defined quality systems or indicate that they have not been set up correctly.


read more ...
26.10.2021 | LOGFILE Feature 40/2021

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.


read more ...
12.10.2021 | LOGFILE Feature 38/2021

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.


read more ...
28.09.2021 | LOGFILE Feature 36/2021

Basis of Cleaning Validation: Setting of PDE Limits

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


read more ...
14.09.2021 | LOGFILE Feature 34/2021

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.


read more ...
31.08.2021 | LOGFILE Feature 32/2021

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.


read more ...
03.08.2021 | LOGFILE Feature 30/2021

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.


read more ...
20.07.2021 | LOGFILE Feature 28/2021

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.


read more ...
06.07.2021 | LOGFILE Feature 26/2021

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.


read more ...
22.06.2021 | LOGFILE Feature 24/2021

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)!


read more ...
08.06.2021 | LOGFILE Feature 22/2021

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.


read more ...
25.05.2021 | LOGFILE Feature 20/2021

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:


read more ...
11.05.2021 | LOGFILE Feature 18/2021

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?


read more ...
27.04.2021 | LOGFILE Feature 18/2021

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.


read more ...
13.04.2021 | LOGFILE Feature 13/2021

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.


read more ...
30.03.2021 | LOGFILE Feature 12/2021

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.


read more ...
16.03.2021 | LOGFILE Feature 10/2021

Rouging When Stainless Steel Corrodes

12 min. reading time | by Herbert Bendlin

 

What is rouging?


read more ...
02.03.2021 | LOGFILE Feature 08/2021

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.


read more ...
16.02.2021 | LOGFILE Feature 06/2021

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.


read more ...
02.02.2021 | LOGFILE Feature 04/2021

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.


read more ...
19.01.2021 | LOGFILE Feature 02/2021

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.


read more ...
15.12.2020 | LOGFILE Feature 48/2020

Online packaging line controls

6 min. reading time | by Vera Werner


read more ...
01.12.2020 | LOGFILE Feature 46/2020

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


read more ...
17.11.2020 | LOGFILE Feature 44/2020

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?


read more ...
03.11.2020 | LOGFILE Feature 42/2020