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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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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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News: EMA
News

EMA: New Q&As for Biological Medicinal Products

The EMA has added a new section to its Q&As on biological medicinal products addressing medicinal products containing secretomes or extracellular vesicles (EVs) obtained from human or animal cells.
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News: Europe
News

EU: Council Adopts the Pharmaceutical Package

On 28 September 2026, the Council of the European Union adopted the EU pharmaceutical package, marking another important step in the legislative process for the comprehensive reform of EU pharmaceutical legislation.
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News: EMA
News

EMA: Report on First Bilateral Meeting with APIC Published

The EMA has published the highlights of its first bilateral meeting with the Active Pharmaceutical Ingredients Committee (APIC). Topics included GMP oversight of API manufacturers, the reuse of recovered solvents and nitrosamine risks.
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News: EMA
News

EMA: Latest Report on the International GMP Inspection Programme for API Manufacturers

EMA has published a new report on the International Active Pharmaceutical Ingredient Inspection Programme, covering the period 2017–2024. During this time, the number of participating authorities increased from ten to 13. Information was shared on 936 inspected sites and 1,684 inspections.
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News: EMA
News

EMA Updates Procedure for Coordinating GMP Inspections

EMA has updated its procedure for coordinating GMP inspections for centrally authorised medicinal products. Version 3 has applied since 10 September 2026 and replaces Version 2. The document forms part of the Compilation of Union Procedures on Inspections and Exchange of Information (CoUP), which comprises the EU procedures and templates for GMP and GDP inspections.
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Swissmedic Updates Guidance on GMP Compliance of Foreign Manufacturers
News

Swissmedic Updates Guidance on GMP Compliance of Foreign Manufacturers

Swissmedic has revised its guidance document “GMP compliance by foreign manufacturers”. The new Version 7.0 has been valid since 7 September 2026. In particular, it introduces new provisions for demonstrating the GMP compliance of manufacturers inspected by the US FDA. 
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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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