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Guidelines for Preparation of VMP (Validation Master Plan)


Learn the preparation of Validation Master Plan and its components as Validation policy, Validation committee etc.

The VMP document shall contain information on the following sections and cover all aspects of qualifications and validations.
Introduction
Objective
Scope
Validation policy
Validation committee
Key personnel and manpower requirement
Facility and equipment qualification
Description of facility including plans
Facility, utilities qualifications
Description and listing of equipments
Key acceptance criteria
Design qualification (DQ)
Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
Re-validation criteria
Description and listing of protocols
Preventive maintenance programme
Process validation
Cleaning validation
Laboratory instrument qualification
Analytical method validation
Computer validation
Change control and approvals
Validation documentation
Validation plan and schedule
Personnel training programme
Reasonable unexpected events (worst case)
Review of VMP
List of relevant SOPs
Glossary of terms
The VMP shall describe the process of preparation, review and approval of protocols. The major contents of protocol and report shall be defined to achieve uniformity in documentation of various protocols.
VMP shall describe the process of execution, review and approval of the validation.
Key people / team responsibilities for validations shall be described.
The VMP shall be printed using format attached. Printing shall be done using the following guidance :
The compiled VMP will have serial pagination.
Design, drawing of the facility shall be included to as annexure to elucidate description of the facility.
VMP will be prepared by a team, reviewed by senior team and approved by GM QA & QC.
The VMP is a controlled document and will be reviewed once a year. Changes to VMP can be made through document change control.
Sr. No.
Text
Font
1
Section title
Arial, (size16)
2
Sub section
Arial, (size 14)
3
Text matter
Arial  (size 11)
4
Text in table
Arial with appropriate font size
5
Autocad drawing
Appropriate legible size letters and diagrams






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