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GMP Magazine – Knowledge for your Practice

Articles, news and information: up-to-date, well-founded and relevant.

Every week, our magazine features new articles on current topics in the field of Good Manufacturing Practice. Our experienced authors provide background knowledge, assessments and answers to the most important questions relating to GMP.

Expert Articles on Good Manufacturing Practice

Read what is important for your work – presented in an understandable way and directly applicable. Whether regulatory requirements, practical solutions or quality management: with our filters, you can find the right reading material straight away.

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EMA: Revision of Annex 6 - Manufacture of Medicinal Gases

EMA: Revision of Annex 6 - Manufacture of Medicinal Gases

EMA and PIC/S have published a concept paper announcing a targeted revision of Annex 6 Manufacture of Medicinal Gases of the EU GMP Guide. The last update dates from 2010. The revision aims to reflect current manufacturing practice, technological progress and lessons learned from the COVID-19 pandemic.

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EMA: Concept Paper on the Revision of Annex 15

EMA: Concept Paper on the Revision of Annex 15

EMA and PIC/S have published a concept paper outlining a targeted revision of Annex 15 (Qualification and Validation).

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Human Resource Management as a Key to Success

Human Resource Management as a Key to Success

The pharmaceutical industry in Germany and other countries, too, faces considerable challenges in the area of human resource management. These problems have far-reaching implications for the competitiveness and innovative power of the industry.

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What do Typical Manufacturing Processes for Sterile Products look like?

What do Typical Manufacturing Processes for Sterile Products look like?

Here's the answer:
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EMA: Reflection Paper on the Qualification of Non-Mutagenic Impurities (NMIs)

EMA: Reflection Paper on the Qualification of Non-Mutagenic Impurities (NMIs)

The EMA has published a new reflection paper outlining its current thinking on the qualification of non-mutagenic impurities (NMIs). The paper addresses recommended approaches for evaluating the safety of new or increased impurity levels, particularly when such impurities exceed the ICH Q3A/Q3B qualification thresholds and are identified after completion of non-clinical toxicology studies.

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EMA: Discussions on the Revised ERA Guideline

EMA: Discussions on the Revised ERA Guideline

During the second industry stakeholder webinar on the revised guideline on environmental risk assessment (ERA) for medicinal products for human use, the European Medicines Agency (EMA) addressed key implementation challenges observed during the first year of application.
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EMA: New Q&A on Product Lifecycle Management (PLCM)

EMA: New Q&A on Product Lifecycle Management (PLCM)

The EMA has published new Questions & Answers on the use of the Product Lifecycle Management (PLCM) document, clarifying its role within the EU variations framework for post-approval quality changes.
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EMA: New Q&A for Co-Processed Excipients

EMA: New Q&A for Co-Processed Excipients

The EMA has published new Questions & Answers on co-processed excipients (CoPEs) used in solid oral dosage forms, introducing a harmonised, risk-based regulatory approach applicable to human and veterinary medicines.

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GMP & GDP – a Quick Guide

What is GMP? 

Basics, objectives, and requirements of Good Manufacturing Practice – explained concisely for both beginners and professionals. 

See "What is GMP?"

What is GDP? 

Get a brief overview of Good Distribution Practice – with links to further reading. 

See "What is GDP?"

Frequently Asked Questions about our Knowledge Content

Our articles on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are aimed at all professionals who bear responsibility along the pharmaceutical supply chain. This includes employees from production, quality assurance, logistics and distribution, as well as auditors, government representatives and consultants. The magazine offers practical information, current developments and clearly presented background information – providing support for everyone who needs to implement regulatory requirements reliably and efficiently in their day-to-day work.

The quickest way to find relevant content is to use the filter in the magazine: simply select the desired publication year, narrow down the articles by topic and specify the desired article type: feature, news or question of the week. This allows you to tailor the content to your area of expertise without having to search for long.


Our content is created by specialist authors with in-depth industry expertise and is editorially reviewed. We attach great importance to addressing legal requirements, guidelines and industry trends in a timely manner and presenting them in an understandable way. This ensures that at the time of publication our articles are both up-to-date and reliable. 

  • The News section addresses new developments and changes right away. 
  • Features are usually excerpts from our products or summaries of GMP events. 
  • The Questions of the Week offer practical insights.

To ensure you don't miss any new content, you are welcome to subscribe to our newsletter LOGFILE free of charge. You will then receive a regular overview of new articles, the latest news and practical tips directly in your inbox.

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