This process validation report template helps pharmaceutical manufacturers create FDA-compliant documentation for equipment and process qualification. Capture equipment criticality and risk assessments, define environmental requirements and utilities, list relevant SOPs, and record calibration methods and results. Compare acceptance criteria against performance test outcomes, log deviations with justifications and impact, and conclude on equipment or system validity. Sections support dispensing, gowning, mixing, filling, tableting, encapsulation, freeze drying, container closure, quarantine, and release. Digital signatures for validation manager, head of quality assurance, and production officer are included.
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