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 will be a new stage in routine production called „continued process verification“.
With the revision of Annex 15 EU GMP Guide the EU is going in the same direction: Validation is a lifecycle with pharmaceutical development als 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.
Since 1987 the FDA Guideline on Process Validation has been the basis for qualification and validation. Within the new FDA programme “Pharmaceutical cGMPs for the 21st Century” there was an announcement for a revision of the guideline. A new FDA Policy Guide of 2004 gives some hints to the new validation approach. In November 2008 the new “Guidance for Industry Process Validation: General Principles and Practices” was published as a draft and came into operation in January 2011. That is now FDA’s „current thinking“. Chapter 1 of the EU GMP Guide gives hints for more emphasises on process capabilities and varieties within process validation also in Europe. EMA´s Process Validation Guidance and also the revised Annex 15 which come into force on 1 October 2015 takes a life cycle approach to process validation.
The addressees of the event are qualified staff charged with or responsible for validation activities, such as commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering industry and consultants.
Teilnehmerstimmen
