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
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.
|
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
|
Also see: Guidelines for Preparation of Site Master File (SMF)
Get ready to use editable documents in MS-Word FormatView List
No comments:
Post a Comment
Please don't spam. Comments having links would not be published.