GMP Trends and Analyses!

Welcome to the GMP Journal. We inform you about the current GMP trends. Our analyses, interpretations, practical examples and background reports will help you with the EU/FDA compliant GMP implementation in practice.

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13.08.2020

Nitrosamine Impurities - A Global Challenge for API Manufacturers and Pharmaceutical Companies

Highlights of APIC's 22nd API Conference in Prague. Please read more here

13.08.2020

GMP-Update - What's new in Germany and the EU? - Part 2

The secong part of this series on the changes in GMP regulations happening during the past year covers the EU-US MRA, Annex 1, ICH Q12 and more. Please read more here

13.08.2020

Benchmark of Industry Practices: Surface Cleanliness Monitoring

In the life science industry, surfaces pose different risks for the process depending on whether and how long they are in contact with the medicinal product. Please read more here

13.08.2020

Data Integrity & Data Governance Part 2: What does a Data Governance System look like?

In the second part of this series, you will learn how a data steering system should be structured. Please read more here

13.08.2020

Do you know the ECA Visual Inspection Good Practice Guide?

This ECA guide covers both the manual and automated process of visual inspection. Please read more here

13.08.2020

GMP: the growing issue of theft

The quality, safety and efficacy of medicinal products depend on a whole range of different factors. Drug theft is an increasing issue here. Please read more here

15.01.2020

Medical Cannabis - How to get GMP-ready?

What does the legalisation of cannabis for medicinal purposes mean for national and international legal frameworks?

Please read more here

15.01.2020

GMP-Update - What's new in Germany and the EU? - Part 1

The first part of this series on the changes in GMP regulations happening during the past year covers Nitrosamine Impurities. Please read more here

15.01.2020

FDA/GMP trends in production & technology - Part 2

Second part of the Pharma Congress 2019 conference report: what has changed in the areas of data integrity, modern qualification, etc.? Please read more here

15.01.2020

Supplier Qualification and Outsourcing

Outsourcing is a critical process in the pharmaceutical industry. A whole series of quality assurance requirements are laid down in the corresponding GMP regulations. Please read more here

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