How to Make Validation Master Plan for New Facility

Validation Master Plan

The Validation Master Plan also known as VMP is a documented plan to outlines the principles involved for qualification of a facility or part of a facility that defines the layout of the operation, the associated utilities and systems, equipment, and the processes to be validated and provides a written program for achieving and maintaining a qualified facility.

Validation Master Plan also provides information as to the extent of the qualification and validation (Installation Qualification, Operational Qualification & Performance Qualification) required documentation, SOP, acceptance criteria and responsibilities.

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Contents of Validation Master Plan

Following are the basic content of the Validation Master Plan:

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1.  The first page contains Title of the Document and details of facility, address and types of products being manufactured in the facility.

2.    Next page contains revision history from initial to latest version including details of each revision.

3.  Next page contains details like name, department, designation with sign date personnel who have approved, reviewed and approved the VMP. Each section shall have the information as mentioned below:

         a)  Prepared By    :   Signature of the person who has prepared the VMP. 

         b)    Review By      :   Signature of the person who has prepared the VMP.

              c)   Approved By  :   Signature of the person who has prepared the VMP.

4.    Table of contents: This section contains a table of all contents with page no.

5.  Objective: This section describes the intent of the Validation Master Plan with respect to the facility for which this is made..

6.   Scope: It describe the extent of the facility (includes its details) to which Validation Master Plan is applicable.

7.  Responsibilities: This contains the role and responsibility of cross functional department including the service provider such as who will do what. 

8.  Validation Policy: This section describes about the firm’s overall approach and intention of all qualification & validation activities to be performed.

9.  Facilities, Systems, Equipment & Process: This section contains the brief summary of particulars which are to be validated. Generally this includes Facility, Equipment, Instruments, Computer, System, Utilities (HVAC / AHU, Water, Air, etc), Validation (Method, Process, Cleaning, Etc.)

10. Plan and Schedule: This section contains the time line of planning of validation and schedule including initial and routine. 

11.  Acceptance Criteria: This section contains the rationale for developing acceptance criteria for each qualification and validation.

12. Change Control and Deviation Management: This section describes the actions to be taken if a change is proposed and how to address if any deviation occurs during the implementation of the VMP or execution of Qualification & Validation.

13. Re-validation & Re-qualification: This section describe the reason, frequency and extent of the Re-validation & Re-qualification of each activity like equipment, utility qualification, Process, Cleaning Validation. 

14. Documents: This section stats about the requirement of related documents like Standard operating procedure, Calibration, Preventive Maintenance and Training, etc.

15. References: This section describes about the reference documents, SOP, Guideline related to the qualification & validation activity which are the base to prepare the VMP.

16.  Abbreviations: Full form of all abbreviations which are mentioned in VMP.

17.  Annexure: List the annexure, which are enclosed to VMP. Generally this include the various qualification & validation schedules. If requires template of the Installation, Operational and Performance Qualification Protocol & Report can also be included to the VMP.

Review and Revision of Validation Master Plan

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The Validation Master Plan should be reviewed at defined frequency (generally once in two year) or whenever there is a modification, expansion or addition in the existing facility.

Template of Validation Master Plan

Validation Master Plan can be prepared as per following template but can be modified as per the requirements: 

VALIDATION MASTER PLAN
VMP No.		Effective Date
Page No.: x of y