Process Validation (PV)

From WikiBioPharm

Process Validation involves the evaluation, sampling and testing of production batches at critical process steps to "establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes." (FDA's Guideline on General Principles of Process Validation)

The sampling plan should be based on an evaluation of the process such that critical process steps receive the most scrutiny.