RESOURCES Validation Master Plan
Validation Master Plan
The Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-Operation Scheme (PIC/S) defines the Validation Master Plan (VMP) as a summary document of the organization’s overall philosophy, intentions and approach in establishment of performance adequacy. The VMP must present an overview of the entire validation procedure including its organizational structure, content and planning.
The VMP is an aid for the management, the validation team and the Good Manufacturing Practice (GMP) inspectors. Using the VMP, the management can determine the inclusions of the validation program with respect to time, people and money. It will also help them understand the necessity of the validation program. For the members of the validation team, a VMP outlines the tasks they are responsible of. GMP inspectors use the VMP as a guide in understanding the organization’s approach to the validation process and in organizing all validation activities.
Scope of the Validation Master Plan
The VMP must cover all validation activities related to critical technical operations including the change control system for both products and processes. These validation activities comprise Prospective Validation, Concurrent Validation, Retrospective Validation and Re-validation. The qualification of critical manufacturing and control equipment is also a necessary inclusion.
A separate VMP must be prepared for large projects (i.e. construction of a new facility). The creation of this new VMP must be a part of the Total Project Management.
Format and Content of the Validation Master Plan
The PIC/S further suggests subjects that must be included in the VMP:
- Introduction
- Organizational Structure of all Validation Activities
- Plant/Process/Product Description
- Specific Process Considerations
- List of Products/Processes or Systems to be Validated
- Key Acceptance Criteria
- Documentation Format
- Required SOPs
- Planning and Scheduling
- Change Control
