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Validation Master Plan

Validation Master Plan is a documented plan for validation of a facility which identifies the layout of the operation, the associated utilities and systems, and process to be validated.

Validation Master Plan Outline

  • Objective
  • Scope
  • Background
  • Acronyms and Definitions
  • References
  • Regulatory Strategy
  • Quality Systems
  • Facility Design
  • Validation Approach
  • Acceptance Criteria
  • Results
  • Revalidation
  • Calibration
  • Maintenance
  • Responsibilities
  • Schedule