Based on outstanding questions and observations from PDA members and industry in general, there is significant interest in the development of a Continued Process Validation/Ongoing Process Validation (CPV/OPV) PDA Technical Report. During recent Process Validation Interest Group discussions over the past several years, the following items were discussed and commented:
There is a need to:
• Expand and clarify the CPV/OPV requirement defined in TR60.
• Clarification of terms, e.g. Continuous, Continued Process/Quality Verifications (CQV).
• Suggest statistical tools and where and when to use (or not use)
• Guide and understand how to apply CPV/OPV for both new and legacy products
• Provide examples representing multiple dosage forms
• Define the CPV/OPV versus Annual Product Reviews (APR) and Product Quality Review (PQR) relationship (They are not the same.)
• Define what signals that should be tracked and trended within CPV such as critical quality attributes (CQAs), critical process parameters (CPPs), in-process controls (IPCs), critical material attributes (CMAs), etc.
• Define how often CPV should be reported out
• Define how signals and trends should be reacted to within CPV/OPV
• Define how to apply quality risk management principles (QRM) to CPV/OPV
• Define the relationship between stage 2b and stage 3.
▪ When and how to reduced enhanced sampling
• Define short term and long term CPV (How to select long term control limits