Example Validation Master Plan | IVT - Pharmaceutical Technology

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Tim Fields
Example of process validation life cycle

This Validation Master Plan serves as a summary of the overall strategy for the validation of a facility. This Validation Master Plan provides an overview of the each process and describes the validation approach along with supporting validation rationale.

This VMP addresses the all activities related to equipment, utilities, processes, systems, and procedures that may impact the product quality.  Specific systems, equipment, utilities, and procedures to be qualified and processes to be validated shall be determined based on documented risk assessment.

The purpose of the validation plan is to demonstrate that the critical equipment, systems, and processes perform as designed and intended.  All validation will be conducted prospectively following written and approved protocols.  Change control and qualification of equipment and systems will be conducted in a manner consistent with a company's policies and procedures.  Specific equipment, systems, and processes to be validated will be determined based on a documented risk assessment.  

Download the example Validation Master Plan.

Download the accompanying presentation "Writing Effective Validation Protocols and Validation Master Plans," from IVT's 15th Annual Validation Week, Philadelphia, PA, October 2009.

This article was originally published for IVT - read article on IVT here: Example Validation Master Plan | IVT.

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