The new EU GMP Chapter 1 in Pharmaceutical Development

The Directorate-General for Health and Consumers (DG SANCO) of the European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called "Pharmaceutical Quality System". Chapter 1 was amended in order to align with the concepts and terminology described in the ICH Q10 tripartite guideline on Pharmaceutical Quality System and includes comprehensive changes. The deadline for coming into operation is 31 January 2013!

Some of the changes are very comprehensive. This already becomes clear from the title, which was changed from "Quality Management" to "Pharma Quality System". This new term can be found constantly in the document. 

Chapter 1 emphasises that GMP "applies to the lifecycle stages from the manufacture of investigational medicinal products [IMPs], technology transfer, commercial manufacturing through to product discontinuation" but that Quality Management "covers all matters, which individually or collectively influence the quality of a product". Therefore, "Quality Management incorporates Good Manufacturing Practice." When it comes to pharmaceutical development, the extension of the Pharmaceutical Quality System remains optional. But if implemented it should "facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities".

For ECA members, we have created a document comparison contrasting the requirements of the current version of Chapter 1 with the new requirements. In this document, you can see exactly where changes and deletions have been made. The document comparison can be found in the ECA Members Area.

Here you can find the new "Chapter 1 Pharmaceutical Quality System" of the EU-GMP Guide.

How new methods can facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities is distributed in the new Workshop on Innovation Excellence in Berlin (30/31 October 2012).

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)