Validation on the move: How should the Annex 15 of the EU GMP Guide be revised?

With the finalisation of the new FDA Guidance on Process Validation in 2011, a validation life cycle has become state of the art. Validation types like prospective, concurrent, retrospective validation and revalidation are not mentioned any more. Also, qualification activities are mentioned in this guidance, but DQ, IQ, OQ terms are not. The EMA recommends a validation life cycle in their draft Guideline on Process Validation as well. But this paper is focused on Marketing Authorisation. Therefore the EU Annex 15 should also be revised. A very vague concept paper is available which the EMA is requesting comments for.

Now we would be interested to find out what your thoughts are with regard to the planned revision. For that purpose the ECA has prepared a brief questionnaire, and we would appreciate it if you took some minutes to complete it if you haven't had the time to do so yet. As usual, your statements are confidential. Furthermore, you will find an overview about the results in one of the coming ECA Newsletters. Details will become available for members of ECA´s Validation working group and will be presented at the 5th European GMP Conference on 6.-7 June. In addition the survey results will be forwarded to the EMA for the improvement of the Annex 15.

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