Skip to main content Skip to search Skip to main navigation
News: GMP Compliance Adviser

Now available: Chapter on Contamination Control Strategy in the GMP Compliance Adviser

In the context of the revised Annex 1 (we reported), the Contamination Control Strategy (CCS) is currently an issue everyone is talking about. This concept must be implemented by 25 August 2023 – when Annex 1 comes into force.

The CCS is an overview document, similar to the Site Master File (SMF), and will play an important role in future inspections. The knowledge portal GMP Compliance Adviser provides important information on this topic. The new chapter explains what is meant by Contamination Controll Strategy and which topics it should include. You will also find helpful tips on how to put this requirement into practice.

For further information you can subscribe to the GMP Compliance Adviser. In this way, you gain access to current regulations and valuable practical tips for everyday GMP work.

>>> More information and order

By the way: As a subscriber to our GMP newsletter LOGFILE, you will soon have the opportunity to get a sneak peek at the new chapter. Subscribe now!

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

News: EMA

EMA Clarifies Batch Numbering for Parallel-Traded Medicines

EMA updated its GMP/GDP Q&A collection by revising the answer to Question 4 concerning Chapter 5 of the EU GMP Guide. It explains which batch numbers should appear on the packaging of parallel-traded medicines.

Read more
Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Cleaning Validation: When PDE Reports and the Worst-Case Selection do not Align

Robust PDE reports form the basis of risk-based cleaning validation. This article highlights common deficiencies identified during GMP inspections and explains how they can be avoided.

Read more
Question of the Week | GMP-Verlag

Why is it Important to use Consistent Microbiological Air Monitoring Methods in Pharmaceutical Cleanrooms?

Here's the answer:
Read more
News: Europe

EDQM: New Working Party on 3D-printed Medicinal Products

The European Pharmacopoeia Commission (EPC) approved the creation of a working party on 3D-printed medicinal products. Its aim is to support the development of appropriate quality standards in the European Pharmacopoeia (Ph. Eur.).
Read more
EMA: 14 New Nitrosamines for Appendix 1

EMA: 14 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.
Read more
WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO: Draft Revision of its Guidelines on Quality Risk Management

WHO published a revised draft of its “WHO guidelines on quality risk management”. Working document QAS/26.994 is open for public comment until 15 November 2026.
Read more
Previous
Next