With the new Guidance for Industry “Process Validation: General Principles and Practices”, the FDA requires a new direction. Validation is now a "Life Cycle Process“ with 3 stages:
Continued Process Verification
The focus is on process knowledge and process understanding. Both should be a result of development and verified in routine production. The “magic” 3 batches are not mentioned any more. What is very important nowadays is the term „scientific sound“, and explicit statistics are mentioned. Six Sigma elements (e.g. Design of Experiments, DoE) are also mentioned directly or indirectly. There will be a new stage in routine production called continued process verification.
With the new EU campaign of the revision of the EU GMP Guide also modern process aspects are under discussion.
How can the new requirements be achieved?
How fit the new FDA requirements into European guidelines?
How can process knowledge and process understanding be demonstrated on the basis of development studies?
When is a process valid now?
Which parameters can be used for knowledge and understanding studies?
How can continued process verification be realised?
How can statistics help?
These questions are discussed, and the possibilities for implementation are covered.