ECA publishes revised version of Good Practice Guide on Process Validation

Recommendation

15/16 February 2024

Process Understanding - Live Online Training
Statistical Process Control (SPC) as a tool to get there

Since the publication of FDA´s Process Validation Guidance in 2011, validation has become a life cycle approach with focus on process knowledge and process understanding based on scientific sound principles. In addition, with the revision of Annex 15 of the EU GMP Guide, the EU has also been moving to modern process aspects (e.g. life cycle approach).

The question is how to implement these new requirements - in the USA and  in Europe?

To answer this question, an ECA Working Group has revised the Version 1 of ECA´s Good Practice Guide on Validation. With the revision the group wants 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 revised version comprises 174 pages divided in 5 chapters and 5 annexes (with detailed analyses of the regulatory guidances).

The topics covered are e.g.:

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

The ECA Good Practice Guide on Validation will be officially launched at ECA´s Annex 15 Conference on 25/26 November 2015 in Berlin. All participants will receive a free copy of the document.