PV.pptVIP

Janssen Pharmaceutica Marc Schelstraete Process Validation Q7A Guidelines Q7A: Good Manufacturing practice (GMP) Guide for Active Pharmaceutical Ingredients (API) Process Validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API, meeting its predefined specifications and quality attributes. Validation of API process should be completed before commercial distribution of the final drug product manufactured from that API 3 possibles approaches to process validation: Prospective Concurrent Retrospective Scope of Process Validation at Janssen All new and existing API’s for use in human and veterinary drug product applications All critical process steps of these API syntheses (see criticality concept Paul Michiels) Critical and key parameters are described in validation protocols and reports Process Validation types Prospective Validationthis is the preferred typevalidation study is completed prior to release and distribution of the resulting productat least three consecutive validation batches are performed Concurrent Validationvalidation study cannot be completed prior to release and distribution of the resulting product of each individual validation batchproduct is released and distributed based on interim validation report Retrospective Validationour procedures do not allow for retrospective validation Process Validation triggered by New process introductions Process transfers to other plant Process or equipment changes / optimizations Upgraded validation requirements Responsibilities Documented evidence (1) Process as decribed in Manufacturing Instruction (Master Formula) Validation Protocol Protocol should specify at least (Q7A) Critical process steps and parameters Acceptance criteria Type of validation to be conducted Number of process runs Documented evidence (2) Validation Report Part 1 :data to release validation batch