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GMP Magazine – News

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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News: EMA
News

EMA Clarifies Batch Numbering for Parallel-Traded Medicines

EMA updated its GMP/GDP Q&A collection by revising the answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains which batch numbers should appear on the packaging of parallel-traded medicines.

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News: Europe
News

EDQM: New Working Party on 3D-printed Medicinal Products

The European Pharmacopoeia Commission (EPC) approved the creation of a working party on 3D-printed medicinal products. Its aim is to support the development of appropriate quality standards in the European Pharmacopoeia (Ph. Eur.).
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EMA: 14 New Nitrosamines for Appendix 1
News

EMA: 14 New Nitrosamines for Appendix 1

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.
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WHO: Draft Revision of its Guidelines on Quality Risk Management
News

WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO published a revised draft of its “WHO guidelines on quality risk management”. Working document QAS/26.994 is open for public comment until 15 November 2026.
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News: Artificial Intelligence
News

Annex 22: Results of the EMA Workshop

On 30 June, the EMA’s Annex 22 Working Group discussed the future scope of the annex with AI experts and representatives of the pharmaceutical industry (as previously reported).
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News: Artificial Intelligence
News

EMA Workshop Regarding Annex 22 "Artifical Intelligence"

The current draft of Annex 22, "Artificial Intelligence", proposes excluding generative AI and large language models (LLMs), as well as probabilistic, dynamic and adaptive AI models, from critical GMP applications. Numerous comments submitted during the public consultation challenged this approach. Instead, the aim should be to support innovation and encourage investment by the pharmaceutical industry.
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FDA: Adjustment of Nitrosamine Limits for Short-Term Use Medicines
News

FDA: Adjustment of Nitrosamine Limits for Short-Term Use Medicines

The FDA has updated its recommendations on Acceptable Intake (AI) limits for nitrosamine impurities. Under certain conditions, the Agency now accepts a Less-Than-Lifetime (LTL) adjustment of AI limits for medicinal products that are not intended for lifetime use. This also represents an alignment with the LTL concept of ICH M7(R2).
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Swissmedic: SMS Registration Becomes Prerequisite for GMP Certificates
News

Swissmedic: SMS Registration Becomes Prerequisite for GMP Certificates

As of 15 November 2026, active substances must be registered in the EMA's Substance Management Services (SMS) database before Swissmedic can include them in establishment licences and GMP certificates for active substance manufacturers. The new requirement results from modifications to the EudraGMDP database.
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GMP & GDP – a Quick Guide

What is GMP?

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?

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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