Which Changes Have to Be Made to the Validation Strategy Due to the New FDA Process Validation Guide?

The new draft of the FDA Guidance Process Validation (see GMP News of 26 November 2008) calls for a "validation life cycle approach". The number of validation runs is not indicated any more. Revalidation is not mentioned any longer, instead the text uses the term "continued process verification". "Process understanding" - also with regard to statistical features - is the centre of attention. In place of DQ, IQ, OQ, the document refers to verification.

However, which concrete changes have to be made to the validation strategy?

The European regulations continue to include the 3-batch model of validation as well as revalidation and also qualification in the phases DQ, IQ, OQ, PQ. To reconcile this contradiction in a new validation strategy will be an important challenge faced by any globally acting enterprise for the next few months.

In order to help you with this task, we have developed a questionnaire addressing questions regarding implementation possibilities and also suggesting possible answers. On the whole, we have compiled 10 short questions for you. We will evaluate your answers and publish them on this website. Naturally, the questionnaire is anonymous. We will send the results to the FDA by the end of the commenting period, i. e. before 20 February 2009.

The survey can be found here. Just fill in the questionnaire and press "send" at the end. Thank you very much in advance for your commitment.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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