ABSTRACT
Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process. Prior to the validation phase, successful technical transfer must be completed with robust information transfer from development to manufacturing. The validation process is used to substantiate the manufacturing process documents, which contains the control strategy of the drug product and the boundary limits of the process consisting of limits of processing variables. Key process parameters (KPP), critical process parameters (CPP) and critical quality attributes (CQA) are used to define the drug product process control strategy. Validation is performed at the target parameters. All other studies to assess the boundary limits must be done prior to validation.
