An NSF International Company Draft EU GMP Annex 15
Wednesday the 12th February 2014
The long expected draft of EU GMP Annex 15 on Validation has been published.
The key points are as follows:
- URS has finally been added to the section on Qualification for Facilities and Equipment, as has Factory Acceptance Testing (FAT)/Site Acceptance Testing (SAT)
- Process Validation is divided into ‘Traditional’ and ‘Continuous Process Verification’ with a hybrid of the two allowed, as per the 2012 draft CHMP NfG on Process Validation
- Even for traditional validation there is no mention of 3 batches, which has been replaced by the requirement that “The number of batches manufactured and the number of samples taken should be based on quality risk management principles …”
- To avoid confusion between continuous process verification and continued process verification, the latter has been replaced by the term ‘Ongoing Process Verification”
- There is a new section on Verification of Transportation
- Cleaning Validation is required to be based on a toxicological evaluation to determine the product specific permitted daily exposure (PDE) value, as per the drafts of Chapters 3 & 5 and the CHMP Guideline on setting health based exposure limits
