SOP For site validation master plan (SVMP) is described in this post which you can follow in the section of the Quality Assurance Department.
INTRODUCTION
Validation Master Plan is a comprehensive document describing the applicable validation requirements for the facility and providing plan for meeting those requirements. Validation Master Plan summarizes the organization’s overall philosophy, intentions and approaches to be used for establishing performance adequately. The Validation Master Plan provides a set of guidelines, instructions and explanations to management for on-time start up of facility operations and validation of existing facilities in compliance with cGMP requirements.
The validation Master Plan is the ultimate guide to FDA, GMP and GLP compliance and allows to more easily achieving satisfactory inspections, new product approval, minimize non conformance, reduce work and rejected lots and avoid recall lots by developing and managing the Validation Master Plan.
OBJECTIVE
The purposes of the VMP are to:
Identify the members of the Validation Committee.
Identify Regulatory requirements.
Identify and describe the facility, systems and equipment to be validated.
Identify and describe products and processes to be validated.
Identify the validation activities that will be undertaken.
Identify the methods by which these activities will be undertaken.
Identify the documentation requirements to support the above activities
SCOPE
The Validation Master Plan (VMP) includes all relevant aspects relating to the production of pharmaceuticals in the production facility at plant. The principle of validation, the organization of qualification and validation, and the design and nomenclature of the documentation and equipment's are also described. The VMP covers all facilities used in the production of all products; the facilities for storing raw materials and finished products, storage, services and the rooms for staff.
VALIDATION TEAM
This Validation Master Plan has been compiled by a Validation Committee (VC) who will also manage its execution. The members of the Validation Committee are listed below and by their signatures in each protocol acknowledge their responsibilities to ensure that all validation activities are carried out as described in this Validation Master Plan (VMP).
It is recommended that the members of the VC should include, but is not limited to the following areas of responsibility and expertise:
Validation Team Members
Validation Manager, (Quality Assurance Manager)
Member from Production (oral, and Sterile)
Member from Quality Control
Member from R & D.
Member from Engineering (Utilities)
Member from Calibration
Member from Maintenance
PROCEDURE
Validation is used for establishing documented evidence of the facility and processes.
Information generated during actual process.
Validation steps will be described as follow.
Validation Master Plan
Design Qualification
Installation Qualification
Operation Qualification
Performance Qualification
Process Validation
Cleaning Validation
Analytical Method Validation
Computer system validation
Validation Report
Revalidation
FACILITY
DESCRIPTION
BRIEF DESCRIPTION
OF THE FIRM
Size of Site &
Area:
|
Plot Area |
|
|
Built up Area( ground floor) |
|
|
Built up area ( first floor) |
|
|
Adjacent plot |
|
|
Built up area |
|
|
Total built up area Ground floor |
|
|
Total built up area first floor |
|
|
Grand Total built up area ( ground floor + first
floor + adjacent plot) |
|