Comments about the revision of the EU GMP Annex 15

The revision of the Annex 15 “Qualification and Validation” is expected to be approved by EC in October 2014. The revision of this guideline represents a major change in the philosophy of the validation approach. The traditional approach, which is based on the 80s, is replaced by a dynamic approach integrating the process knowledge as central point and the quality as integral part of the process. The basic principles, which are described in the ICH Q8, 9, 10 AND 11 are fully integrated in the updated Annex 15. Retrospective Validation, Revalidation are not present any more. However, other topics like “Design Space” or “Bracketing” are mentioned as valid strategy. When a new drug substance is developed, the process development, production and QA department should now work close together from the beginning. Intensive teamwork between all parties makes also sense when changes are implemented for registered products (life cycle). We have to think about the new way for working together. In my opinion, that is the biggest challenge, because these new interactions request attitude changes. That is why I would like to encourage all people working in the domains process development, production and QA to take the new approach in consideration as soon as possible. If you want to perform a process development or to execute a process validation “State of the Art”, do not hesitate to contact us. We are fully at your disposal for supporting you!