Guidelines for Preparation of VMP (Validation Master Plan) : Pharmaceutical Guidelines

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.
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 the 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 an annexure to elucidate description of the facility.

VMP will be prepared by a team, reviewed by the 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.
Section title
Arial, (size16)
Sub section
Arial, (size 14)
Text matter
Arial  (size 11)
Text in table
Arial with appropriate font size
Autocad drawing
Appropriate legible size letters and diagrams

Also see: Guidelines for Preparation of Site Master File (SMF)

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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