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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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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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Damage Control: Complaints and Recalls
LOGFILE Feature

Damage Control: Complaints and Recalls

Complaint handling and product recalls are important components of the Pharmaceutical Quality System (PQS). They serve to identify defective medicinal products and ensure that appropriate measures are taken to protect patient safety, as required by law and the competent supervisory authority.

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What are the Phases of a Working Cycle During a Steam Sterilisation Process?
Question of the Week

What are the Phases of a Working Cycle During a Steam Sterilisation Process?

Here's the answer:
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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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EMA: Reduced Testing of Incoming Starting Materials is a GMP Matter
News

EMA: Reduced Testing of Incoming Starting Materials is a GMP Matter

The European Medicines Agency (EMA) published an update to its “Quality of Medicines: Questions and Answers – Part 2”. The revision concerns the section on “Reduced testing of incoming starting materials”.
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What Types of Impurities may be Present in Active Substances?
Question of the Week

What Types of Impurities may be Present in Active Substances?


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There’s Something in the Air – Cleanroom Technology in the Pharmaceutical Industry
LOGFILE Feature

There’s Something in the Air – Cleanroom Technology in the Pharmaceutical Industry

In pharmaceutical manufacturing, clean air is not a subjective perception but a precisely controlled technical condition that is essential for product safety. Heating, ventilation and air-conditioning (HVAC) systems ensure, through airflow management, air filtration and pressure control, that particles and microorganisms are kept away from critical areas. This is based on clearly defined requirements for air changes, cleanliness classes, airflow patterns and pressure concepts, all of which are designed according to the manufacturing process and contamination risk involved.
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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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