Validation Master Plan

The validation master plan (VMP) is a crucial document because it describes the basic concept for the overall site validation program. It is basically the blueprint for a successful validation project. It defines one's approach to validation, applicable references, and requirements of the GMP system. VMP describes the approach to training, procedures for deviation management, and change control, and establishes responsibilities for the entire

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validation project. Equipment processes, cleaning procedures, and relevant analytical tests are listed together with the foreseen protocols for their qualification or validation.

The cleaning validation master plan (CVMP) is intended to be a "live" document that supports the fundamental structure of any manufacturing facility, its equipment and instruments, subsequent operation, and maintenance and cleaning of the equipment for its lifespan for any active pharmaceutical ingredient.

CVMP should present an overview of the entire cleaning validation operation. The core of VMP is the matrix of equipment in the facility, the list of items to be validated based on the matrix, the worst-case scenario, and the planning schedule.

CVMP further provides the basis for validation required for CGMP compliance. This enables any sterile or nonsterile medicinal product that is produced, processed, stored, or distributed, by the manufacturing unit, to be validated for the effectiveness of the cleaning procedure thereof for any related manufacturing equipment under the control of an appropriate quality system.

VMP should provide a cross-reference to other documents, such as SOPs, validation protocols, validation reports, and equipment/product. A rationale for the inclusion or exclusion of validations from the approach adopted is also included.

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