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GMP Magazine – All Articles

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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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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Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers
News

Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers

Swissmedic has revised its Technical Interpretation “Market release and distribution in cooperation with a pre-wholesaler”. The document addresses market release and distribution where a Marketing Authorisation Holder works with a pre-wholesaler (logistics and distribution service provider).
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News: Europe
News

IPEC Updates Two Guides on Pharmaceutical Excipients

The IPEC Federation has updated two key guides on pharmaceutical excipients. The IPEC Composition Guide for Pharmaceutical Excipients (Version 3, 2026) describes an approach for manufacturers to establish excipient composition profiles. The revised version now covers biotechnology- and fermentation-derived excipients, provides further details on component types and physicochemical characterisation, and includes an example composition profile template.
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Applying the FDA’s 7-Step Model for AI/ML Validation in GMP Environments: One Year Later
LOGFILE Feature

Applying the FDA’s 7-Step Model for AI/ML Validation in GMP Environments: One Year Later

Artificial intelligence is becoming increasingly important in GMP-regulated environments, presenting companies with new regulatory challenges. This article summarizes the latest regulatory developments, introduces a validation framework based on the FDA's seven-step model, and outlines initial practical experience with AI/ML validation.

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Question of the Week | GMP-Verlag
Question of the Week

What are the General Requirements for Standard Documents?

Here's the answer:
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News: Europe
News

EDQM: Revised Guidance on Sister File Applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised its Guidance on applications for “sister files” (PA/PH/CEP (09) 141). The revision is intended to support consistent application of the procedure and provide greater clarity on the classification and assessment of the corresponding CEP applications.
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Swissmedic Clarifies Requirements for QR Codes on Medicinal Product Packaging
News

Swissmedic Clarifies Requirements for QR Codes on Medicinal Product Packaging

Swissmedic has revised its guidance document “Mobile technologies” and added two new entries to the related questions and answers. The update follows an increasing number of queries regarding the details and placement of URLs, the positioning of QR codes and their captions.
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News: EMA
News

EMA: Withdrawal of an Application due to Missing Confirmation of a Manufacturing Site’s GMP Status

EMA reported that Scholar Rock Netherlands withdrew its application for Isembyld after evaluation had progressed through the final round of questions. EMA’s provisional view was that the medicine could not be authorised because the applicant had not provided confirmation that the manufacturing site complied with EU GMP requirements.

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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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