GMP LOGFILE: Lead Article

6 minutes reading time | by Rainer Gnibl, PhD

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

5 minutes reading time | by Lea Joos

Shortened excerpt from Chapter 21.C.2.5 of the GMP Compliance Adviser

3 minutes 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 minutes reading time | by Felix Tobias Kern, PhD 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. This specification also prevents inhomogeneities between the individual decision-makers of the QA and between the individual QPs.

6 minutes reading time | by Christoph Frick, PhD

Excerpt from the GMP Compliance Adviser Chapter 16.F and the GMP Series e-book Storage of Medicinal Products

13 minutes reading time | by Axel Radke, Trust Expert Service

8 minutes reading time | by Hedley Rees

5 minutes reading time | by Mark Tucker, PhD

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 minutes reading time | by Christine Oechslein, PhD

7 minutes reading time | ​by Sabine Paris, PhD

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 minutes 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 minutes reading time | by Harald Flechl / Doris Borchert, PhD (editorial editing)

Shortened and edited excerpt from the GMP Compliance Adviser, Chapter 3.E "Cleanroom Construction Components"

5 minutes reading time | by Lea Joos

Shortened excerpt from the GMP Compliance Adviser, Chapter 21.C Frequent deficiencies in GMP inspections, their recurring pitfalls and how to avoid them

8 minutes reading time | by Thomas Peither

5 minutes reading time | by Rainer Gnibl, PhD

7 minutes 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 minutes 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 minutes reading time

5 minutes reading time | by Christine Oechslein, PhD

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

5 minutes 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. Hygienic design refers to the easy-to-clean design of parts, components and production machinery. Hygienic design results in machines with a closed design that have little dead space and are easy to clean.