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GMP Magazine – Knowledge for your Practice

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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How is a QRM process initiated?
Question of the Week

How is a QRM process initiated?

You can view the answer here:
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FDA: Updated Pre-RFD Guidance for Combination Products
News

FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.
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EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs
News

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.
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Data Integrity and Data Governance
LOGFILE Feature

Data Integrity and Data Governance

Data integrity is a key element in the pharmaceutical quality assurance system which has gained importance in recent years, especially from the viewpoint of the authorities. In GxP-regulated companies, managers are responsible for identifying and minimising risks to data integrity (“data governance”).

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EMA Clarifies “Novel or Complex Manufacturing Process” Definition
News

EMA Clarifies “Novel or Complex Manufacturing Process” Definition

In its Quality of Medicines Q&A – Part 1, the EMA has clarified how “novel or complex manufacturing processes” should be interpreted for variation categories Q.II.b.1 (new/replacement finished product manufacturing site) and Q.II.b.4 (change in batch size).
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EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines
News

EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

The Environment Committee of the European Parliament has issued its opinion on the proposed EU Regulation to strengthen the availability of critical medicines. Key recommendations include fast-track permitting, simplified environmental assessments, and support for strategic manufacturing projects to boost EU production capacity.
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Operation of Computerised Systems – An Overview
LOGFILE Feature

Operation of Computerised Systems – An Overview

The rapid development of information technology has made computerized systems central to the pharmaceutical industry. They are essential for managing sensitive data, controlling production processes, and ensuring regulatory compliance. This article provides an overview of key considerations for operating computerized systems.
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What are the individual steps of an efficient QRM process?
Question of the Week

What are the individual steps of an efficient QRM process?

You can view the answer here:
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GMP & GDP – a Quick Guide

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? 

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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