Prospective validation is normally expected for processes introduced since the publication of ICH Q7. The concept of retrospective validation remains acceptable as an exception for existing, well established products prior to the implementation of ICH Q7 [ICH Q7, Section 12.44]. If regulatory discussions redefine a step as critical, which had previously been considered non-critical, a protocol describing retrospective analysis of data together with the commitment for concurrent or prospective validation may be an option. Regardless of the type of validation, the quality system should confirm the ongoing robustness of the process (e.g., product quality review).
