Update to EU GMP Chapter 5 – Production

Chapter 5 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. Dominic Parry provides a useful introduction to the main changes and implications at Inspired Pharma.

There are four main areas in which Chapter 5 have been updated, concerning prevention of cross-contamination in production, control and approval of suppliers, testing of incoming materials and notification to the regulatory authority of potential product shortages to the market.

For further details, see Inspired Pharma

Posted by Tim Sandle