In our news EMA published a concept paper on the revision of the Annex 15 we reported about the planned revision of Annex 15. Now, the European Commission has published the draft of the Annex 15.
Compared to the original 11 pages of Annex 15 the draft has now 17 pages. The above-mentioned concept paper is mentioned as a reason for the revision, i.e. adjustments to changes partially to part 1 of the EU GMP Guide, changes in Annex 11, adjustments to the ICH Q8-11 documents, to the EMA Process Validation draft and changes in manufacturing technologies.
Below is a short summary of the major changes.
The revision is very extensive. Influences of the ICH Guidelines Q8, 9, 10 (and 11) are clearly visible - even in the glossary. The subject Design Space (ICH Q8) is now also covered in the area Process Validation. Many risk considerations (ICH Q9) are now mandatory. The life cycle approach and process knowledge (ICH Q10) are now included as well. Deviation management gained in significance. Third party services are now authorized explicitly if the supplier has been qualified correspondingly. This is a positive adaptation to reality. The mention of preliminary approvals - e.g. in the case of deviations - is good for a next (validation / qualification) stage, if there is a documented assessment showing that there is no significant impact on the next stage. Unfortunately a clear differentiation between qualification (based on equipment and facilities) and validation (related to processes) is missing. This is a shortcoming that unfortunately exists in many European regulations.
Other important changes compared to the current version are:
Conclusion: All in all there is an abundance of new requirements, which partly only represent the state of the current technology. And partly the "problems" remain in the details. A detailed analysis will follow.
The draft comment period is relatively short and ends (unfortunately) already end of May 2014.
Here you will find the Draft EU GMP Annex 15 for Download