VALIDATION MASTER PLAN (VMP)

What is VMP

Brief information about Qualification, Validation and calibration of Equipment, Instrument and System.
A document providing information on the company’s validation work programme. It should be
define details of and timescales for the validation work to be performed. Responsibilities relating to the plan should be stated.

Which Guideline follow for preparation of VMP

PIC/S (PI 006), WHO TRS 961, Eudralex Volume 4

Contents of VMP.

 Cover Page, Table of contents

 Approval of document

 Introduction, Objective, Scope

 Quality policy

 Validation policy

 Quality Risk Management Policy

 Responsibility

 Validation / Qualification Schematic Flow

 Validation and Qualification approach

 Revalidation and Requalification approach

 Qualification Activity

 Facility Qualification

 Qualification and Validation of Utilities

 Equipment Qualification

 Laboratory Instruments and Equipment

 Personnel Qualification

 Products and Process Validation

 Exhibit batches process validation

 Cleaning Validation

 Analytical Method Validation

 Hold Time Study

 Computerized System Validation

 Vendor Qualification Program

 Change Control, SOP, Training, Environment Monitoring, Preventive Maintenance /calibration

 Terms and Definitions

 List of Annexure

 Revision History

 References

Review Period

Any changes after approval of VMP shall be recorded in Annexure-II for keeping a track of changes taken place.

VMP shall be revised at end of every calendar year, or as and when required through change control management system.

Validation master plan is prepared at the initial stage of commissioning of a facility after the civil design,type, drawings are established.

The VMP shall be prepared by QA, it should be reviewed by Department Head and approved by PlantHead and QA Head.

Storage Period

Validation Master Plan shall be store by QA department for perpetual.