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  • TR 42 Revision 2016
  • TR 60-3: Ongoing Process Verification
    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