Validation Approach

 


  • Process Validation is documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API meeting its predetermined specifications and quality attributes.
  • Out of the three approaches to validation (Prospective, Retrospective, and Concurrent), Prospective Validation is mostly preferred with some exceptions where other approaches can be used.
  • Prospective Validation should be performed on an API process and should be completed before commercial distribution of the final drug product manufactured from that API. This validation should normally be performed for all API processes in which those operations are determined to be critical to the quality and purity of an API.
  • Retrospective Validation can be performed for well-established processes that have been used without significant changes in raw materials, equipment, facilities, systems, or processes. Also, when in-process acceptance criteria and impurity profiles are readily available, retrospective validation can be considered as an approach. The number of batches selected for this validation should be sufficient and representative of all batches made during the review period, including failed batches to validate process consistency.
  • Concurrent Validation can be conducted when data from replicate batches is unavailable due to limited numbers or in frequency. Prior to completion of this validation, batches can be released and used in the final drug product for commercial distribution based on systematic observation and testing of the API batches.

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