GMP: Handling of APIs and Excipients - New Guidelines in Chapter 5 of EU GMP Guide

The European Commission published the re-revised version of draft chapter 5 - Production - of the EU GMP Guide for comment. The chapter entitled \"Production\" deals with many aspects which are relevant for quality assurance and quality control too - like, for example, purchasing, controlling and processing APIs and excipients, as well as topics with regard to reduced sampling and reduced testing.