2011工艺验证指南解读.pptVIP

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Concurrent Release in the PV Guidance In the PV guidance, the term “concurrent release” is meant exclusively in terms of the process performance qualification (PPQ) study protocol. It means releasing a lot(s) included in a pre-planned study protocol before the study is completed, data collected and analyzed, and conclusions drawn. PV Guidance definition Concurrent Release: Releasing for distribution a lot of finished product, manufactured following a qualification protocol, that meets the [lot release criteria] standards established in the protocol, but before the entire study protocol has been executed. * Concurrent Release in the PV Guidance “Conclusions about a commercial manufacturing process can only be made after the PPQ protocol is fully executed and the data are fully evaluated. If Stage 2 qualification is not successful (i.e., does not demonstrate that the process as designed is capable of reproducible performance at commercial scale), then additional design studies and qualification may be necessary. The new product and process understanding obtained from the unsuccessful qualification study(ies) can have negative implications if any lot was already distributed. Full execution of Stages 1 and 2 of process validation is intended to preclude or minimize that outcome.” * Concurrent Release Why does this matter? Under normal circumstances, a firm’s decision to begin to commercially distribute product from a particular process is based on having achieved that high degree of assurance threshold. Unless there are special circumstances (e.g., orphan drugs, short shelf-life radiopharmaceuticals, medically necessary drugs to alleviate short supply) there is no reason to distribute products before that threshold has been reached. In these special circumstances, the benefit of having these drugs available to patients is judged to be greater than the risk of a lower de