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GMP LOGFILE: Lead Article

Insufficient cleaning validation

24.11.2020

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.

Can the author of a GMP document also act as its reviewer?

17.11.2020

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?

Criticality classifications of deviations

10.11.2020

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.

What is the point of "heating" medicinal products to 15–25 °C?

03.11.2020

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.

Thoughts on the transport of pharmaceuticals from a claims handling perspective

27.10.2020

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.

Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?

20.10.2020

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.

Regulatory compliance - issue identification

13.10.2020

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.

Optimum GMP training concept: modular and inclusive e-learning

06.10.2020

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.

ICH Update Quality Initiatives

29.09.2020

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".

Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

22.09.2020

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.

Sliding doors in cleanrooms - "no go" or "best practice"?

16.09.2020

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.

Inadequate handling of deviations: the cause "human error"

08.09.2020

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.

Two different pairs of boots: GMP for APIs and GMP for medicinal products

04.08.2020

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:

Filter integrity test

28.07.2020

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.

Substance-based medical devices

21.07.2020

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?

Work instructions, records and documentation

07.07.2020

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.

Hygienic design of pharmaceutical manufacturing processes - example: tablet press

30.06.2020

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.

GMP:READY: GMP for Engineers

23.06.2020

5 min. reading time

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