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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: Medical Devices
News

EMA: Harmonisation of Combination-Product Quality Assessment

EMA’s Combination Products Operational Group (COMBO) is working to improve alignment between notified body opinions (NBOps) and pharmaceutical quality assessment, according to its report on the meeting held on 8 October 2026.
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PIC/S: Revision of the Framework for International Cooperation
News

PIC/S: Revision of the Framework for International Cooperation

PIC/S has revised the framework governing its international cooperation. The updated Pharmaceutical Inspection Co-operation Scheme, PIC/S 1/95 (Rev. 7), was adopted in Istanbul on 2 November 2026 and entered into force on the same day.
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EMA: Revised Nitrosamine Q&As
News

EMA: Revised Nitrosamine Q&As

EMA published an updated question-and-answer document on nitrosamine impurities in human medicinal products.

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FDA Updates Framework for Coordinating Facility Evaluations and Inspections
News

FDA Updates Framework for Coordinating Facility Evaluations and Inspections

FDA has revised its framework for collaboration between the Center for Drug Evaluation and Research (CDER) and the Office of Inspections and Investigations (OII). Version 2.0 of the Concept of Operations (ConOps), effective October 21, 2026, supersedes the original June 2017 version.
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News: Europe
News

EU: Singapore Added to List of Recognised Third Countries for API Importation

The European Commission recognises Singapore’s GMP requirements and regulatory oversight of active substance manufacturers as equivalent to EU requirements. Once the decision enters into force (15 November), Singapore will join the EU list of recognised third countries for the importation of active substances.
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PIC/S/EMA/WHO: New Q&A on Annex 1
News

PIC/S/EMA/WHO: New Q&A on Annex 1

The revision of Annex 1 also made it necessary to update the previous PIC/S interpretation document, PI 032-2, “GMP Annex 1 Revision 2008, Interpretation of Most Important Changes for the Manufacture of Sterile Medicinal Products”. Based on a Swissmedic draft from 2023, the joint PIC/S–EMA–WHO working group developed a new Q&A document.
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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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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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