A Validation Master Plan, also referred to as “VMP”, outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility.
The following content can be applied to a MVP:
Approvals: Signatures and job titles of who will author and approve the VMP.
Publication Record: The revision history of the VMP.
Responsibilities: Who is responsible for what part of the validation/qualification?
Introduction: Describes the company and location as well as the product, process, and equipment.
Scope: Describes the limits of the validation project including which equipment and process are included and which are not.
Design Description: Describes the design of the process such as what are the critical processes and how they affect product quality.
Qualification/Validation: Rationale for why a process is validated or not validated. This will be decided by the impact on quality of the product and whether verification can be performed and documented to comply with applicable regulations.
This section will note why or why not validate a process based on an impact classification of the facility, utility, process or equipment. This is based on an impact assessment based on three levels:
- Direct on product quality
- Indirect on product quality
- No impact on product quality
The same impact assessment will be performed for the equipment used in the validation. Describe the type of validation, whether it is retrospective, concurrent or prospective and why. Describe the format for protocol and references including company protocols or ones form the literature. The process validation protocols should include the sampling plan for ongoing quality monitoring and training requirements.
Computer System Qualification: Describe rationale for decisions regarding which computers are and are not validated based on an impact assessment as to whether they are quality relevant.
Qualification Matrix: A tabular list or table with all of the utility and process systems associated with the project and which systems are being validated. The list includes a description of the equipment and a column for IQ, OQ, PQ and other relevant qualifications such as CSV computer system validation and cleaning.
List of Required Standard Operating Procedures: In tabular form or a table to list all associated procedures.
Equipment & Utility System Descriptions: A brief outline of the purpose of the instrument and what qualification tests/acceptance criteria are needed.
Quality Systems: Document how the process will be kept in a validated state with a list of SOPs that support this.
This will constitute the companies documentation system including:
- CAPAPM/Calibration
- Training
- Change control
- OOS out of specification results
- Deviations
- Failure investigations
- Audits
References: List all of the regulations including state and federal and company policies that are relevant for the processes validated in the VMP.
