With publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires a new direction. Validation is now a „Life Cycle Process” with 3 stages:
- Process Design
- Process Qualification
- 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 is a new stage in routine production called „continued process verification“.
With the revision of Annex 15 EU GMP Guide in 2015 the EU is going in the same direction: Validation is a lifecycle with pharmaceutical development as basis and also a stage 3 is mentioned, called Ongoing Process Verification. In Europe 3 validation approaches are now possible – traditional, continuous and hybrid.
- How can the new requirements be achieved?
- How fit the FDA requirements into European guidelines and vice versa?
- 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/ongoing process verification”
- be realised?
- How can statistics help?
These questions are discussed, and the possibilities for implementation are covered.