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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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What are the quality requirements for pharmaceutical gases?

What are the quality requirements for pharmaceutical gases?

You can view the answer here:
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EMA: Update on the Guideline “Stability Testing for Variations”

EMA: Update on the Guideline “Stability Testing for Variations”

The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).
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EU: Proposal for a European Biotech Act

EU: Proposal for a European Biotech Act

The European Commission has presented a proposal for a European Biotech Act aimed at strengthening Europe’s biotechnology potential and accelerating the translation of innovation from the laboratory to the market.

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EU: Proposal for Simplification of Medical Device Rules

EU: Proposal for Simplification of Medical Device Rules

The European Commission has proposed targeted reforms to simplify the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, IVDR) and to address structural implementation challenges.
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EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

The EMA has published a concept paper outlining a future revision of Annex 3 (Manufacture of Radiopharmaceuticals) of the EU GMP Guidelines. The paper was developed in collaboration with PIC/S and adopted by the GMDP Inspectors Working Group (IWG) at its November meeting.

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EMA: Q&A on QP Certification Without Physical EU Import

EMA: Q&A on QP Certification Without Physical EU Import

The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.

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EU: Agreement on the Pharmaceutical Package

EU: Agreement on the Pharmaceutical Package

On 11 December, the European Commission, the European Parliament, and the Council of the European Union reached a provisional agreement to update Europe's medicinal products regulatory framework.

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EMA: Updated Q&As for Biological Medicinal Products

EMA: Updated Q&As for Biological Medicinal Products

EMA has updated its Q&A on biological medicinal products, addressing topics that previously required clarification or were subject to differing interpretation. The latest revision adds six new questions and updates several existing answers.

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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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