Hyperion Pharma Consultancy


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The new FDA/EU Approach to Process Validation

In November 2008 the new „Guidance for Industry Process Validation: General Principles and Practices“ was published as a draft. That is now FDA‘s „current thinking“. The EC Commission has recently published a draft for a revision of chapter 1 of the EEC GMP Guide. This draft gives hints for more emphasises on process capabilities and varieties within process validation also in Europe.

With the new FDA Guidance on Process Validation the FDA requires a new direction. Validation should now follow a life cycle. The revison of the EU GMP Guide also indicates that process capabilities and variations are more emphasised in Europe. How can the new requirements be fulfilled? When is a process valid now? How can statistics help? These questions are discussed during the ECA course on 6/7 December, which also covers implementation possibilities. Please see the programme for further information.

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