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
FDA’s 21 CFR Part 820 (Quality System Regulation) and the EU’s Annex 15 of the EudraLex Volume 4,PIC/S (PI 006-3), WHO TRS 1019 - Annex 3,
Contents of VMP.
1. Cover Page, Table of contents
2. Approval of document
3. Introduction, Objective, Scope
4. Quality policy
5. Validation policy
6. Quality Risk Management Policy
7. Responsibility
8. Validation / Qualification Schematic Flow
9. Validation and Qualification approach
10. Revalidation and Requalification approach
11. Qualification Activity
12. Facility Qualification
13. Qualification and Validation of Utilities
14. Equipment Qualification
15. Laboratory Instruments and Equipment
16. Personnel Qualification
17. Products and Process Validation
18. Exhibit batches process validation
19. Cleaning Validation
20. Analytical Method Validation
21. Hold Time Study
22. Computerized System Validation
23. Vendor Qualification Program
24. Change Control, SOP, Training, Environment Monitoring, Preventive Maintenance /calibration
25. Terms and Definitions
26. List of Annexure
27. Revision History
28. 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 the 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 Plant Head and QA Head.
Storage Period
Validation Master Plan shall be store by QA department for perpetual
