As per urgent need of product , batch is planned without packing material with deviation but due to any reason packing material would not delivered on time and hold time is exceeded more then 10 days also assay result of re-test sample was found fail ( initial result of assay was pass) then what will be done to destroy batch. OOS is required or not
As per urgent need of product , batch is planned without packing material with deviation but due to any reason packing material would not delivered on time and hold time is exceeded more then 10 days also assay result of re-test sample was found fail ( initial result of assay was pass) then what will be done to destroy batch. OOS is required or not.
Answer-
Please correlate results of the initial assay and assay after 10 days holding time, with the established Hold time of this product.
This is a deviation from the established hold time as well as manufacturing the batch without ensuring availability of packaging materials (due to urgency). And also raise OOS for assay failure. Please investigate to find out the reason(s) for assay failure.
After thorough investigations in both cases, you may re-process/rework the batches as per your internal SOP and instructions from R&D. Please keep the re-processed/reworked batches for stability studies.
Re-processed / reworked batches must meet the finished product specifications in both cases before being released by QA.
2 Likes
This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.