DOCUMENT OVERVIEW
About this document
This pharmaceutical Validation Master Plan template provides a framework for organising qualification and validation activities at an API manufacturing site. It outlines departmental responsibilities, equipment and utility qualification, process and cleaning validation, analytical method validation, computerized system validation, change control and revalidation.
The editable Word document includes 14 annexures containing equipment and instrument lists, system records and planners for validation, calibration and preventive maintenance. Designed for Quality Assurance, Quality Control, Production, Engineering and IT teams, the template requires site-specific information, procedures, review and approval before use.