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GMP LOGFILE: Lead Article

Online packaging line controls


6 min. reading time | by Vera Werner

Brief spots on autumn conferences


5 min. reading time | by Thomas Peither


In September 2020 the series of virtual autumn conferences of PDA and ISPE started. We were present and pick out some excellent sessions with this LOGFILE feature.

Certification of products manufactured outside the EU


6 min. reading time | by Rainer Gnibl


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 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?


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


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?


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


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?


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


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?

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