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Validation Master PlanS

WHAT IS A MASTER VALIDATION PLAN?

A Validation Master Plan is a written plan and living document that establishes the intent of the manufacturer or owner to meet specific legal (CFR/FDA) and internal regulatory and quality objectives. The Master Validation Plan describes in detail, what systems exist in the facility and their operational requirements. It defines what production/process, laboratory facility/utility and computerized automation systems will require validation and why. The Master Validation Plan also defines what systems will not be validated and provides an engineering and regulatory basis for not validating specific systems. The Master Plan identifies the validation team, and the specific responsibilities of each team member. The plan establishes the validation approach, validation schedule and may define specific Validation Protocols (I.Q.'s, O.Q.'s, P.Q.’s) to be developed and executed. The plan would establish validation acceptance criteria, facility and system classifications, and required system Standard Operating and Maintenance Procedures (SOP’s).

WHY SHOULD I HAVE A MASTER VALIDATION PLAN?

What does a Master Plan do for me ? A Validation Master Plan establishes, in writing, a logical, approved, prioritized plan to validate, or not validate research, laboratory, manufacturing and computerized (IT based) automation systems. If systems are not validated, or validation is “in process”, and you are inspected or challenged by the FDA, the manufacturer can avoid an immediate Adverse Findings Report (483), by providing the FDA inspector with written proof of the “intent and schedule” to validate specific systems.

HOW IS A MASTER VALIDATION PLAN DEVELOPED?

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Email: rsickinger@mfgauto.com