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GMP LOGFILE: Lead Article

Regulatory compliance - issue identification


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


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


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


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"?


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"


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


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


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


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


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


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


5 min. reading time

FMD alerts in 2020 – where we are a year into legislation


9 min. reading time | by Grant Courtney

Environmental Risk Assessment: ERA Reports


8 min. reading time


1 Introduction: environmental risk evaluation

Purpose and content of a management review


5 min. reading time | by Stephanie Blum


A management review is carried out on a regular basis to check the suitability and effectiveness of the pharmaceutical quality system (PQS). It is one of the most effective PQS tools available.

Challenges lurking in manufacturing


8 min. reading time | by Dr. Sabine Paris


Experts:            GMP inspector Lea Joos, Christian Gausepohl, PhD, QP and Head of Quality Unit



7 min. reading time | by Brian Matye, Jeanne Moldenhauer, Susan Schniepp


Question: How often should I review my SOPs?

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