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.

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.

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.

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.

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?

9 min. reading time |

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.

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.

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.

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.

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

Cleaning Validation

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.

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.

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".

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

7 min. reading time | by Christine Oechslein, PhD

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.

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).

7 min. reading time | by Alexandra Fürst

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.

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.

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.

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).

7 min. reading time | by Torsten Knöpke

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:

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.

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.

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?

8 min. reading time |

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.

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.

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.

8 min. reading time | by Thomas Trantow, PhD

Definition of the types of Excel applications

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.

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:

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.

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.

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.

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.

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.

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.

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

7 min. reading time |

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

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.

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.

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.

12 min. reading time | by Thomas Peither

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.

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.

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.

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.

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.

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:

7 min. reading time | by Stephanie Blum

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

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.

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.

10 min. reading time | by Chistian Gausepohl

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

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:

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.

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?

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).

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.

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.

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.

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.

5 min. reading time | by Markus Veit

Introduction

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

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.

12 min. reading time | by Herbert Bendlin

What is rouging?

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.

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.

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.

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.

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:

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.

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.

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.

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.

6 min. reading time | by Vera Werner

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.

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

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.

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?

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.

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.

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.

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.

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.

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.

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".

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.

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.

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.

8 min. reading time | by Thomas Peither

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:

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.

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?

7 min. reading time

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.

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.

5 min. reading time

9 min. reading time | by Grant Courtney

8 min. reading time

1 Introduction: environmental risk evaluation

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.

8 min. reading time | by Dr. Sabine Paris

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

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

Question: How often should I review my SOPs?

9 min. reading time | by Petra Rempe and Martin Mayer

An excerpt from the GMP Compliance Adviser, Chapters 19.A Agency expectations of quality risk management and 19.B Application and benefits of QRM in the pharmaceutical industry

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.

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.

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.

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.

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?

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.

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.

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.

15 min. reading time | by Sabine Rabus

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

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.

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].

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.

10 min. reading time

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

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.

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

Selection and procurement

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?

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.

5 min. reading time | by Martin Mayer

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

9 min. reading time | by Doris Borchert

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

6 min. reading time | by Thomas Peither

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

4 min. reading time | by Frank Böttcher

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

6 minutes reading time | by Felix Tobias Kern

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

10 minutes reading time | by Sabine Paris

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

6 min. reading time | by Rainer Gnibl

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

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

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

4 min. reading time | by Sabine Rabus

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

10 min. reading time | by Tim Sandle

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

5 min. reading time | by Markus Veit

2 min. reading time

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

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

3 min. reading time | by Markus Limberger

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

12 min. reading time | by Sabine Rabus

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

6 min. reading time | by Christine Oechslein

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

10 min. reading time | by Thomas Peither

Robotics in Future's Factory

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.

10 min. reading time | by Thomas Peither

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

4 min. reading time | by Markus Veit

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

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

Incoming goods and dispatch

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

8 min. reading time | by Sabine Paris

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

5 min. reading time

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

5 min. reading time | by Frank Boettcher

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

4 min. reading time | by Stephanie Blum

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

6 min. reading time | by Sabine Paris

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

5 min. reading time | by Sabine Paris

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

6 min. reading time | by Doris Borchert

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

7 min. reading time | by Sabine Paris

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

9 min. reading time | by Paulino Alonso

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

5 min. reading time | by Ulrike Reuter

Significance of risk analysis for a qualification

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

7 min. reading time |

Introduction

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

5 min. reading time | by Josef Künzle

Change analysis (CA)

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

8 min. reading time | by Doris Borchert

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

5 min. reading time | by Fritz Röder

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

4 min. reading time | by Christine Oechslein

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

4 min. reading time | by Harald Flechl

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

8 min. reading time | by Dr. Sabine Paris

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

9 min. reading time | by Sabine Rabus

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

4 min. reading time | by Cornelia Wawretschek

Personnel

5 min. reading time | by Hanfried Seyfarth

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

5 min. reading time | by Simone Ferrante

5 min. reading time | by Christine Oechslein

Why is it necessary to "manage" quality?

5 min. reading time | by Thilo Gukelberger

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

5 min. reading time | by Jens Hrach

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

6 min. reading time

GMP Requirements for Process Validation

9 min. reading time | by Doris Borchert

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

6 min. reading time | by Rainer Gnibl

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

6 min. reading time | by Mark Crawford

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

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.

5 min. reading time | by Josef Künzle

Change analysis (CA)

6 min. reading time | by Susanne Sailer

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

5 min. reading time | by Martin Mayer

Change analysis (CA)

6 min. reading time | by Thomas Peither

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

5 min. reading time | by Fritz Röder

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

12 min. reading time | by Fritz Röder

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

12 min. reading time

14 min. reading time | by Gary Bird

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

6 min. reading time | by Ruven Brandes

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

6 min. reading time | by Thomas Peither

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

6 minutes reading time | by Michael Hiob

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

10 min. reading time | by Andrew Love

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

5 min. reading time | by Simone Ferrante

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

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

8 min. reading time | by Thomas Peither

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

7 min. readingtime | by Dr. Markus Limberger

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

Layout of a Cleanroom Air Handling Unit

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

6 minutes reading time

by Harald Flechl

Practical Issues on Supply Chain and Good Distribution Practice

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

6 minutes reading time

by Susanne Sailer

2017 – The GMP Regulations Report

by Sabine Rabus

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

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither

Industry 4.0 - Inspiration for the Pharmaceutical Industry?

A report on the ISPE European Annual Meeting 2018

8 minutes reading time

by Thomas Peither

Principles of Qualification

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

6 minutes reading time

by Michael Hiob, PhD

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

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

6 minutes reading time

by Sabine Rabus and Christine Gräßlin

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

6 minutes reading time

by Walid El Azab

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

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

4 minutes reading time

by Sabine Rabus and Christine Gräßli

General principles of hygienic design

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

8 minutes reading time

by Richard Denk

Sampling Frequencies

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

6 minutes reading time

by Hanfried Seyfarth, PhD

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

6 minutes reading time

A commentary by Ruven Brandes and Fritz Röder

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

6 minutes reading time

by Walid El Azab

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

6 minutes reading time

A commentary by Ruven Brandes and Fritz Röder

Implementing and Monitoring Data Integrity Measures

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

5 minutes reading time

by Markus Veit, PhD

Key learnings from serialisation projects – Part 2

6 minutes reading time

by Andrew Love and Stephen McIndoe

Key learnings from serialisation projects – Part 1

6 minutes reading time

by Andrew Love and Stephen McIndoe

Risk Analysis in the Equipment Life Cycle

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

5 minutes reading time

by Ulrike Reuter

Root Cause Analysis – An Essential Enabler

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

8 minutes reading time

by Martin Mayer

Ask Our Experts – Part 2

4 GMP-Questions which might be of your interest

7 minutes reading time

by Sabine Rabus

International GMP – Six Questions for Jacques Morénas

5 minutes reading time

Intermediate Bulk Container Systems

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

5 minutes reading time

by Richard Denk

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

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

8 minutes reading time

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

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

5 minutes reading time

by Fritz Röder

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl

Calibration of laboratory instruments

An excerpt of the GMP Compliance Adviser, Chapter 14.D.4

5 minutes reading time

by Josef Künzle, PhD, Wolfgang Nedvidek, PhD

Ask Our Experts – Part 1

6 GMP-Questions which might be of interest to you

7 minutes reading time

by Sabine Rabus

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

6 minutes reading time

by Fritz Röder

8 Golden Rules for Personnel Hygiene

An excerpt from the GMP Compliance Adviser, Chapter 11.B.5

4 minutes reading time

by Christian Gausepohl, PhD

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

6 minutes reading time

by Dr. Tim Sandle

Physical monitoring of cleanrooms

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

by Dr. Hans H. Schicht

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

6 minutes reading time

by Dr. Tim Sandle

Technology Transfer Phases

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

5 minutes reading time

by Christian Gausepohl, PhD

Data Integrity – Old Wine in New Skins?

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

7 minutes reading time

by Sabine Paris, PhD

Data Integrity – Old Wine in New Skins?

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

7 minutes reading time

by Sabine Paris, PhD

Human Resource Management: Qualification requirements and requirement profiles

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

by Michael Hiob, PhD

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

5 minutes reading time

by Sabine Paris, PhD

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

5 minutes reading time

by Sabine Paris, PhD

Checklist Performance Qualification

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

by Hans H. Schicht, PhD

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

Types of Biotechnological Active Substances

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

by Dr. Rainer Gnibl

Manufacturing Innovation - PDA Annual Meeting 2017, Anaheim

8 min. reading time

by Thomas Peither

GMP-Compliance-Index 2017

Join in now and further your knowledge!

by Thomas Peither

Changes in USP <1231>: Water for Pharmaceutical Purposes

8 min. reading time

by Fritz Röder

by Dr. Christine Oechslein

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

by Dr. Christine Oechslein

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

85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

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

by Dr. Christine Oechslein

A Challenge: Complex Product and Process Flows

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

3 min. reading time

by Rainer Gnibl

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

Data Integrity is a Must!

5 min. reading time

A contribution from Thomas Peither

Chemical Active Substances – Special Risks

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

4 min. reading time

by Stefan Kettelhoit, PhD

130 Elements You Need for a World-Class Technical Agreement

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

by Dr. Christine Oechslein

Formalizing a Risk Assessment for Excipients

by Frithjof Holtz

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

A comment by Fritz Röder and Ruven Brandes

(reading time 5 min)

by Fritz Röder and Ruven Brandes

Independent and Linked CAPA Systems

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

3 min. reading time

by Dr. Bernd Renger

Document Access for GMP Inspectors and Auditors of Notified Bodies

Your question – our answer – Part 2

(5 min. reading time)

by Dr. Sabine Paris

24 GMP documents You Should Know About–

A Concise Review of Everything New in 2016

by Sabine Rabus

What do GMP compliance and GEP mean?

An excerpt from the GMP Compliance Adviser

(4 min. reading time)

by Thomas Peither

Temperature monitoring and control

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

(3 min. reading time)

by Dr. Margit Gieseler

Executing Sterile Filtration

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

by Ruven Brandes

Sampling Frequencies

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

by Dr. Hanfried Seyfarth

Managing Outsourced GMP Activities Successfully

GMP Series PDF Download

An excerpt from the GMP MANUAL

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

170 Questions You Should Ask Your Supplier

An excerpt from the GMP Series GMP Supplier Assessment Questionnaire

3 min. reading time

by Cornelia Wawretschek

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

(5 min. reading time)

by Dr. Sabine Paris

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

(5 min. reading time)

by Dr. Sabine Paris

Alert and action levels and specifications

An excerpt from the USP <1231> Download

by Fritz Röder