Validation Master Plan

Master Validation Plan Outlines

Validation master plans summarize all validation activities, and systematically help in translating design requirements into production requirements, while helping to maintain control of the validations.

Brought to you by one of our esteemed presenters at Medical Device Validation Week 2018 is an introductory group of outline documents for each type of master validation plan. 

Types of Master Validation Plans:

  • Design Project Master Validation Plan: A documented plan containing validation evidence for items utilized during product development, design verification, and design validation activities for a project under Design Controls. In other words, it lists all the validation activities required to test the design requirements during design verification and design validation activities. 
  • Design Transfer to Production Master Validation Plan: Used to translate design requirements into production or manufacturing requirements by listing all the requirements that can and will be tested in production. The plan uses mechanical drawings, product specifications, and other visual representations. 
  • Site Master Validation Plans: A documented plan for the validation of all the areas that are in scope of validation and intended to be maintained in a validation state. In other words, it is a compilation of all the validation activities for each validation area of each site. 
  • Cleaning Master Validation Plans. The inventory and plan for cleaning validation of equipment and tooling involved in the manufacture of the product. Its use is to summarize the validation activities relating to equipment and tooling cleaning processes. Cleaning validation demonstrates that the cleaning process removes residues of interest from the surfaces of equipment and tooling, used to manufacture product, to predetermined levels. Document the equipment cleaning processes that will be validated and those that will not be validated with justification.

This package has outlines for all four types of master validation plans. To be used with Guzman's accompanying presentation, you can streamline your validation processes.

Download the corresponding presentation by Camille Guzman, "Implement an Effective Master Validation Plan" given in March 2018. 

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