A documented program that provides a high degree of assurance that a specific product, method, procedure (e.g., cleaning), or system will consistently produce a result meeting predetermined acceptance criteria.

Validation Master Plan (VMP)

The VMP is a high-level document that establishes an umbrella validation plan for the entire project and summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s validation work programme and defines details of and timescales for the validation work to be performed, including a statement of the responsibilities of those implementing the plan. [23]

Validation Protocol (or Plan) (VP)

A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results. [2]

Validation Readiness Check

not yet defined

Validation Report (VR)

A document in which the records, results and evaluation of a completed validation programm are assembled and summarized. It may also contain proposals for the improvement of processes and/or equipment. [23]


An expression of the degree to which a measurement performed actually measures the characteristic which the investigator wishes to measure (see also reliability above). [25]

Vegetable Sourced

Contains starting materials of plant origin. [6]


The application of methods, procedures, tests and other evaluations to provide objective evidence that the output of a particular operation meets the specified requirements for that operation.


Validation Master Plan


Validation Protocol


Validation Report