Structure of Validation Master Plan

The GAMP Guide suggests the following layout for a Validation Master Plan  

Introduction and Scope Organizational Structure GxP Criticality Assessment Process Validation Strategy Change Control Procedures and Training Document Management Timeline and Resources 

In addition, a Glossary may be added as required to aid understanding of the Validation Master Plan. Bear in mind that not all terms routinely used within the organization will be familiar to those outside it. 

referenee should be made to relevant policies, and where the document fits into the level of planning should be described. The scope and boundaries of the site/area/systems being validated should be defined as appropriate. Reference should also be made to any subordinate Validation Plans, and the period within which this plan will be reviewed should be stated. 

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