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Prospective process validation: Prospective Process validation shall be carried out for all the intermediate stages and Active Pharmaceutical Ingredients prior to the distribution of a new product. [ICH: GMP, EU: GMP, PIC/S: GMP]
Concurrent process validation: Any validated process undergoes a change either for the equipment or addition, deletion of a critical manufacturing process step, scale up or scale down, the same needs to be validated concurrently.
The validation is carried out only after a change of an existing validated process to support the change made or involve with the requirements.
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A subset of prospective validation in which API batches are released for distribution, based on extensive testing, before completion of process validation. Once data from additional batches produced under replicated conditions show uniformity, the process may be considered validated
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Concurrent validation can be conducted when data from replicate production runs are unavailable because only a limited number of API batches have been produced, API batches are produced infrequently, or API batches are produced by a validated process that has been modified. [ICH: GMP, EU: GMP, PIC/S: GMP]
Retrospective process validation: Validation of a process for a product already in distribution based upon accumulated production, testing and control data. [ICH: GMP, EU: GMP, PIC/S: GMP]
