“Qualification and Validation” – public consultation on the revision of EU GMP Guidelines for Medicinal Products (EU GMP part I, Annex 15) launched
After discussion in the working groups in 2013, the DRAFT EU GMP guideline “Qualification and Validation” has entered into the next step being adopted as final draft for public consultation. The document reflects changes to other sections of the EU-GMP Guide such as Annex 11, ICH Q8, Q9, Q10, Q11 and changes in manufacturing technology. Besides the traditional approach to qualification and validation also other aspects such as product life cycle, critical process parameters (CPP), critical quality attributes (CQA), design space, continuous process verification etc. are being covered.