ECA publishes Good Practice Guide on Process Validation

Since the FDA has revised its "old" Validation Guidance in 2011, validation has become a life cycle process with focus on process knowledge and process understanding based on scientific sound principles. The qualification steps DQ, IQ, OQ, PQ and the "magic" 3 batches are not mentioned any more in the new guidance. In addition, with EMA´s new Process Validation Draft Guidance the EU has been also moving to modern process aspects (e.g. life cycle process).

Now, the question is how to implement these new requirements?

To answer this question, an ECA Working Group has developed a Version 1 of a Good Practice Guide on Validation. This document is intended to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do").

The guide contains 163 pages divided in 5 chapters and 4 annexes. The topics covered are e.g.:

  • risk based qualification and validation
  • legacy products
  • statistics
  • case study about process validation in biopharmaceutical manufacturing
  • case study about continuous process verification

The ECA Good Practice Guide on Validation will be officially launched at the 5th European GMP Conference on 6/7 June 2013 in Heidelberg. All participants will receive a free copy of the document. A printed version of the Good Practice Guide will be available for purchase in the literature section of this website.

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