EU-GMP Guide: New Introduction with Clarification of Status of Part III

As mentioned in our previous news, ICH Q9 and ICH Q10 will be adopted as Part III of the EU GMP Guide. In this regard, the EU Commission has revised the Introduction of the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, the so called "EU GMP Guide".

Here, the status of the new Part III is clarified:

"Part III is intended to host a collection of GMP related documents, which are not detailed guidelines on the principles of GMP laid down in Directives 2003/94/EC and 91/412/EC. The aim of Part III is to clarify regulatory expectations and it should be viewed as a source of information on current best practices. Details on the applicability will be described separately in each document."

Besides that, some editorial changes have been made, like the replacement of the term "Quality assurance" with the term "Quality Management".

You can find a comparison of the Introduction with the previous version in the ECA Members Area.

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