PROCESS QUALIFICATION (P2Q)
PROCESS VALIDATION RATIONALE.Prior to process qualification being started,all manufacturing equipment, tooling, any instrumentation that is used to assess or measure a parameter, any utility that is used or could make contact with the product, must be qualified using the standard validation protocols such as DQ, IQ, OQ, PQ, along with the associated VMP, URS, VRA, and VP. At all stages in the process, staff must be working from detailed documented SOP’s. Each production process must be validated, and so must all the equipment used in the execution of these stages. Caution must be used to ensure that all this equipment is adequately labeled and supported by completed company approved validation and calibration documents and protocols. Supporting operations such as cleaning and or sterilization of equipment, and sanitation of premises, must be validated and executed in accordance with an SOP. Similar attention must be given to ensure that staff have been are trained for their allotted tasks and training records are available to confirm this. The validation of the process is carried out by manufacturing three batches of the product that have completed this process stage, using the production process SOP’s. Evaluation of these batches dictates whether you have, or have not, a process that is deemed to be under control.
PROCESS VALIDATION SCOPE.Before reaching the conclusion that a process has been successfully validated, it is necessary to demonstrate that the specified process has not adversely affected the finished product. Where possible, product process validation testing should include testing under conditions that simulate actual use. Product process qualification testing should be conducted using product manufactured from the same type of production equipment, methods and procedures that will be used for routine production. Otherwise, the qualified product may not be representative of production units and cannot be used as evidence that the manufacturing process will produce a product that meets the pre-determined specifications and quality attributes.
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