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A validation master plan is a document that outlines the company’s overall vision, objectives, and procedures to be used to establish performance adequacy. Validation master plan should be agreed by management.
Validation in general requires careful preparation and careful planning of the various steps in the process. In addition, all work should be done in a structured manner according to officially approved standard operating procedures. All observations must be documented and where possible recorded as actual numerical results.
The validation master plan shall provide an overview of the entire validation operation, its organizational structure, its content and planning. Its main components are list of items/checking and planning schedule. All validation activities related to critical technical activities relevant to product and process control within a firm should be included in the validation master plan. It should include all prospective, concurrent and previous validations as well as revalidations.
The Validation Master Plan should be a concise document and should therefore be concise, concise and clear. It should not repeat information documented elsewhere but refer to existing documents such as policy documents, SOPs and validation protocols and reports.
The format and content should include:
• Introduction: validation policy, scope, location and schedule.
• Organizational structure: personnel responsibilities.
• Plant/process/product description: rational for inclusions or exclusions and extent of validation.
• Specific process considerations that are critical and those requiring extra attention.
• List of products/ processes/ systems to be validated, summarized in a matrix format, validation approach.
• Re-validation activities, actual status and future planning.
• Key acceptance criteria.
• Documentation format.
• Reference to the required SOP’s.
• Time plans of each validation project and sub-project.
