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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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FDA: New Draft Guidance on Impurity Specifications for Antibiotics
News

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

The US FDA has issued a new draft guidance (April 2026) on Impurity Specifications for Antibiotics.
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EDQM: Guidance on Traceability of Medicines in Hospitals
News

EDQM: Guidance on Traceability of Medicines in Hospitals

The EDQM has published new guidance on the traceability of medicines in hospital settings. The aim is to improve traceability up to the point of administration and strengthen patient safety.
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Contamination Control Strategy (CCS) – Not Just an Extended Site Master File
LOGFILE Feature

Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

At the GMP-PharmaCongress in Wiesbaden, GMP inspector Frank Sielaff (Regional Authority in Darmstadt, Germany) shared practical insights from recent inspections, high-lighting deficiencies in CCS implementation.

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Which Measures are Crucial for Implementation and Monitoring of Data Integrity?
Question of the Week

Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Here's the answer:
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EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals
News

EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

In their „Horizon Scanning Report“, EMA and HMA have recommended updates to the regulatory framework to keep pace with developments in radiopharmaceuticals. Due to their unique characteristics these products require specific regulatory and scientific approaches.
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FDA: PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing
News

FDA: PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing

The U.S. Food and Drug Administration has started the PreCheck Pilot Program, a strategic initiative to strengthen the U.S. pharmaceutical supply chain by facilitating domestic manufacturing.
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GMP Meets Radiation Protection – How Do They Fit Together?
LOGFILE Feature

GMP Meets Radiation Protection – How Do They Fit Together?

The manufacture of radiopharmaceuticals requires simultaneous compliance with the EU GMP Guide and radiation protection regulations, which can lead to conflicting objectives between product safety and personal protection. Technical solutions such as negative pressure systems and lead-lined cells, as well as early consultation with the authorities, are crucial for implementation that complies with both GMP and radiation protection requirements.
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How can the Specific Requirements for Sterile Products be Taken into Account in the Quality Management System?
Question of the Week

How can the Specific Requirements for Sterile Products be Taken into Account in the Quality Management System?

Here's the answer:
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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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