GMP LOGFILE: Lead Article

5 min. reading time | by Xenia Dimont

The term "PUPSIT", which stands for the Pre-Use Post-Sterilization Integrity Test, has been included in the revised Annex 1. While the term is new, the requirement to check the integrity of a sterilizing filter after it has been sterilized and before it is used for sterile filtration is not new. This has been included in Annex 1 since 1998.

5 min. reading time | by Thomas Peither

In-house logistics encompasses all the processes required to manage and transport materials within a company. This is particularly important in the pharmaceutical industry, where not only efficiency but also compliance with safety and quality standards are crucial. Efficient logistics can help streamline production, cut costs, and ensure legal compliance. The provision of safe and effective medicines relies on pharmaceutical companies prioritising material management and flow. It ensures the availability, quality, and compliance of materials.

5 min. reading time | by Christine Oechslein, PhD

Carrying out quality testing internally may be a complex process, but it also has many advantages. A solid knowledge of product properties, stability and degradation products is built up over time in a laboratory and can be particularly valuable when carrying out quality risk analysis. However, some tests can be outsourced to external partners.

5 min. reading time | by Doris Borchert, PhD

When was the last time you went to a concert? What images have stuck? The conductor guiding his orchestra through the repertoire with grand gestures and high commitment? The first violin, connecting conductor and orchestra? Or the musicians working as a coordinated team, bringing the music to life? Either way, hopefully it was an amazing experience.

7 min. reading time | by Sabine Paris, PhD

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 occurred in the setting of limits for the validation of cleaning processes. Instead of the previously used criteria, such as 10 ppm or 1/1000 of the therapeutic dose of the foregoing product, the only acceptable criterion is now a toxicological risk assessment based on PDE values.

5 min. reading time | by Harald Flechl

Both of the terms "clean up period" (Annex 1) and "recovery time" (ISO 14644-3, informative part B.4) are often used to describe the same procedure but they are completely different from each other. These test methods have no validity with respect to the airborne microbes, which depend greatly upon the number of persons in the room as well as their clothing and activity.

5 min. reading time | by Christine Oechslein, PhD

For most manufacturing and packaging processes it is technically not feasible or much too expensive to check every single unit of resulting product (100% control). Instead, random samples are relied on which are taken on an ongoing basis at specific times during the process (in-process controls), or random samples are taken for quality control of the final product prior to market release.

However, it would hardly be possible to find the famous needle in the haystack using these random samples. For this reason, validated manufacturing and packaging processes are required by law in addition to the final product checks and IPCs. The company must prove that the processes are all so reliable that, under everyday routine manufacturing conditions, they result in medicinal products of a high and reproducible quality.

7 min. reading time | by Xenia Dimont, PhD

The concept of contamination control is not entirely new in the context of the EU GMP Guideline - the basic principles are already contained in Chapter 5 of the Guideline regarding cross-contamination and in Annex 2 regarding specific risks for biological products.

7 min. reading time | by Birte Scharf, PhD

Regulatory framework for ATMPs in the European Union

To address the specific requirements for manufacturing ATMPs, separate GMP regulations were published as Part IV of the EU GMP Guidelines in late 2017.

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.

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.

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.

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.

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.

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.

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.

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.

‘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.

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.

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.