Follow
Unlike prospective validation, concurrent validation occurs in parallel with product production.
This means that companies can distribute batches commercially before approval of the validation process, provided that the product must meet pre-defined quality specifications. By then it should be kept in quarantine.
Its rationale should be documented along with supporting data used to make a decision.
Although all documentation requirements are potentially valid, this approach is decided based on product or market constraints such as short shelf-life, high demand, low supply, etc.
Involvement of all stakeholders in concurrent validation review and approval, including regulatory agencies, is recommended because FDA considers this validation procedure to be a rare condition.
The validity of such process should be documented along with the performance evaluation and conclusion justification.
FDA has outlined several expectations for concurrent disclosure of PPQ batches:
=>> Before commercial distribution of PPQ batches, expect to prepare a dedicated protocol addressing this particular case.
=>> Possible scenarios and logic should be part of the PPQ protocol. In addition, full performance of the PPQ protocol and data evaluation are required before any conclusions can be drawn.
=>> Stage 2 – Additional process design and qualification becomes necessary if process qualification fails.
=>> Many released together must comply with cGMP and other regulatory requirements, even if the PPQ batch has pending clearance. Also, it must pass all acceptance criteria outlined in the PPQ protocol.
=>> Firms can give up a lot when they meet the level of confidence required for the quality attributes applicable to that product.
=>> A fast-track assessment of market complaints and responses is expected when many are released simultaneously.
