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How To Write An Effective Validation Master Plan

A validation master plan (VMP) is a document that details the way a company will operate, who has control over the various aspects of the validation activities, and how production, quality control, and personnel management will be directed. 

  • The VMP allows companies to agree upon and document an overall validation strategy, which can be provided to regulators to serve as clear justification for the validation effort.
  • The VMP also allows manufacturers to show they are in control of their quality system and focused on quality.

A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Masterplans also assist an organization with validation strategies or to provide control over a specific process. 

The VMP is different from a validation procedure (SOP), which describes the specific process for performing validation activities. The VMP is beneficial for planning purposes because it identifies anticipated resource needs and provides key input into scheduling of project timelines. It documents the scope of the validation effort including impacted product, processes, procedures, facilities, equipment, and utilities.

Functions of Validation Master plan

The VMP has several functions including -

  • Management education: Upper management is not always aware of the necessity for validations and qualifications. The VMP educates management by presenting an assessment of the potential impact of manufacturing processes on product quality.
  • Project monitoring and management: The VMP includes validation schedules and timeline for project completion.
  • Auditing the validation program: The VMP describes all activities involved in the validation of processes and the qualification of manufacturing equipment and utilities. 
  • Planning purposes: The VMP identifies anticipated resource needs and provides key input into scheduling of project timelines.
  • Documenting the scope of the validation effort.

VMP includes impacted:

  • Product,
  • Processes,
  • Procedures,
  • Facilities,
  • Equipment &
  • Utilities.

All VMPs must include the following:

1.Title page and authorization (approval signatures and dates)

2. Table of contents

3. Abbreviations and glossary 

4. Validation plan 

5. Purpose and approach to validation 

6. Scope of validation 

7. Roles and responsibilities 

8. Outsourced services 

9. Deviation management in validation 

10. Change control in validation 

11. Risk management principles in validation

12. Training

13. All validations 

14. Validation matrix 

15. References


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