GMP LOGFILE: Lead Article

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