Follow
– Validation Master Plan (VMP)
– Validation Protocols (VP)
– Validation Reports (VR)
– Standard Operating Procedures (SOP)
i. Validation Master Plan:
– Contains key elements of the validation program.
– Summary of facilities, systems, equipment, and processes validated (and to be validated).
ii. Validation Protocol:
– Is a detailed document relating to a specific part of the validation process.
– Describes the procedure to be followed for performing validation.
– Description of the equipment to be used (including calibration before and after validation).
iii. Validation Report:
– Record of results obtained during the performance of the validation.
– Includes evaluation, analysis, and comparison of results with acceptance criteria by the responsible personnel.
– Results should meet acceptance criteria and satisfy the stated objective.
