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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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EMA: Q&A Paper on Measures to Prevent Microbial Contamination of Non-Sterile Medicinal Products
News

EMA: Q&A Paper on Measures to Prevent Microbial Contamination of Non-Sterile Medicinal Products

The EMA has published a new Q&A paper on technical and organisational measures to prevent microbial contamination of non-sterile medicinal products.
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FDA: Updated Compliance Program for Preapproval Inspections
News

FDA: Updated Compliance Program for Preapproval Inspections

The FDA has revised its Compliance Program 7346.832, “Preapproval Inspections”. The updated program describes the planning, conduct and evaluation of preapproval inspections (PAIs) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
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EMA: Revised Q&A MRA EU-USA
News

EMA: Revised Q&A MRA EU-USA

The EMA has updated its Questions and Answers on the EU-US Mutual Recognition Agreement (MRA). The update follows the completion of the FDA's assessment of all EU authorities responsible for GMP inspections of veterinary medicinal products on 29 May 2026.
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WHO: Draft on Regulatory Ovesight of Disposal of Medical Products
News

WHO: Draft on Regulatory Ovesight of Disposal of Medical Products

WHO published a draft consultation document on regulatory oversight of disposal of medical products throughout the lifecycle.
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EU: GMP Annex 19 Updated
News

EU: GMP Annex 19 Updated

The European Commission has published a revised version of Annex 19 “Reference and Retention Samples”. The update mainly affects requirements for reference and retention samples of parallel imported, parallel distributed and parallel traded medicinal products.
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ANVISA: Expands Recognition of Foreign GMP Authorities
News

ANVISA: Expands Recognition of Foreign GMP Authorities

Brazilian health authority ANVISA has updated the requirements for the recognition of Equivalent Foreign Regulatory Authorities (AREE) and the administrative procedures for Good Manufacturing Practice (GMP) certification (CBPF) through Normative Instruction IN 451/2026. The aim is to streamline and accelerate regulatory processes.
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EDQM: Guidance on Reporting on Disappearances of Medicinal Products
News

EDQM: Guidance on Reporting on Disappearances of Medicinal Products

The EDQM has published guidance supporting the implementation of Recommendation CM/Rec(2024)3 on reporting medicinal products that disappear from the legal supply chain due to theft, loss or diversion. The initiative follows a European survey that identified shortcomings in reporting and co-ordination of such incidents.

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EMA: 9 New Nitrosamines for Appendix 1
News

EMA: 9 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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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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