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GMP LOGFILE: Lead Article

Certification of products manufactured outside the EU


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

Insufficient cleaning validation


5 minutes reading time | by Lea Joos


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

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


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?

Criticality classifications of deviations


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.

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


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

Thoughts on the transport of pharmaceuticals from a claims handling perspective


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

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


8 minutes reading time | by Hedley Rees

Regulatory compliance - issue identification


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.

Optimum GMP training concept: modular and inclusive e-learning


8 minutes reading time | by Christine Oechslein, PhD

ICH Update Quality Initiatives


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".

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


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.

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


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"

How do you organize GMP knowledge and relevant news in your organization?


8 minutes reading time | by Thomas Peither

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


5 minutes reading time | by Rainer Gnibl, PhD

Filter integrity test


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.

Substance-based medical devices


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?

Work instructions, records and documentation


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.

Hygienic design of pharmaceutical manufacturing processes - example: tablet press


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.

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