SOP on Validation Master Plan (VMP)
Objective: To lay down a procedure for preparation of Validation Master Plan (VMP) for facility.
Scope: This SOP describes the preparation of validation master plan for the facility, area, equipments, processes, instruments, utilities and analytical methods for Formulation plant.
Responsibility:
Officer/Executive-QA shall be responsible for preparation of Validation Master Plan.
In charge-QA shall be responsible for checking of validation master plan for adequacy.
Head –QA shall be responsible for approval of validation master plan.
Accountability: Head-Q.A shall be accountable for implementation and compliance of SOP.
Procedure:
Validation master plan shall be prepared at the initial stage of commissioning of a facility after the civil design, type and models equipment and utility drawings are established.
The Quality Assurance shall prepare validation master plan.
Head Q.A. shall approve validation master plan.
Formating for Validation Master Plan:
The Validation Master Plan should be on A4 Size paper with font type Arial only and font size 11.
The header should be in side the border with the margin 1”.
Page margin should be 1” for top/left & bottom and 0.7” for right margin.
The width of page border should be 1 pt.
The page border from (text) = top 4 pt & bottom 4 pt / right & 12 pt.
Cover page of VMP:
The cover page of VMP shall be without Header and footer and the page numbering shall be start from the cover page but page no. shall not display on cover page.
The cover page shall contain following information:
Validation Master Plan (font size 36)
Document No.(font size 11)
Supersedes (font size 11)
Effective Date (font size 11)
Review Date (font size 11)
No. Of Pages (font size 11)
Site Address (font size 20)
The design of cover page is given below:
VALIDATION MASTER PLAN
| Document No. | Supersedes | Effective Date | Review Date | No. Of Pages |
The numbering of Validation Master Plan shall be assigned as follows:
The first three characters ‘COM’ denote the “Company Code”.
The 4th character shall be always slash forward ‘/’.
The 5th, 6th & 7th character ‘VMP’ shall denotes the “Validation Master Plan”.
The 8th character shall always be slash forward ‘/’.
The 9th & 10th character shows the document no. in VMP.
The 11th character shall always be dash ‘-’.
The 12th & 13th character shows the “revision no.”
Place the approval page to approve the Validation Master Plan and the approval page shall be as follows:
| Prepared By (QA) |
Checked By | Reviewed By (QA) | Approved By (Head – Quality) | ||
| Production | Engineering | Warehouse | |||
Header of Validation Master Plan shall be as follows:
| Company Name and address | |
| Title: Validation Master Plan | Page x of y |
| Document No.: NLL/VMP/01-00 | Effective Date: |
The font type shall be Arial with font size for first line of header shall be 14 and rest will be of 11 font size.
Validation master plan shall contain information as follows:
A brief description of the company and the location where the facility is installed.
A brief description of the facility with layouts showing the location of equipment, man and material movements, Air and Area classification.
List of products planned for manufacturing in the facility.
List of equipment and utility systems.
As built Drawings of the Utility systems.
Process description and Flow chart of the product(s).
Brief description of the key equipment and Utility systems.
Validation master plan will describe the guideline about the qualification procedure of the facility, utility systems, equipment/ instrument, procedure for process validation, cleaning validation.
The document describes the outline procedure for design, installation, operational and performance qualification of equipment, instruments, utility systems. The methodology for the validation study shall be described in the Validation Protocol.
Validation Master Plan provides a brief description of different studies that are to be undertaken for the evaluation of the performance of particular equipment, instruments, utility systems and the process validation.
The document describes the approval procedure of the validation protocols and validation reports.
A validation schedule shall be prepared which describes the frequency at which different equipments, instruments are validated/ calibrated.
Facility, Utility systems, equipment/ instrument, process validation, cleaning validation, analytical method validation shall be revalidated for their performance as per the pre approved validation protocol and also the revalidation studies for process simulation.
The frequency of revalidation may be amended based on the trend data and cGMP requirement, however the revalidation are conducted in the event of :
Shifting of equipment from one place to another
Change in the major component of the equipment
Major maintenance done on equipment or on key part of the utility system
Modifications in the utility systems
Changes in the qualification criteria and specifications.
Such changes may also attract revalidation of process Simulation/ Process validation studies.