Complaint trending was reviewed for the lot code provided.There were 13 similar complaints found (all complaints are from 2 sites in denmark). no sample was returned for evaluation to date. batch records were reviewed, and all testing results met specifications for this lot code at the time of release. additionally, there were no deviations noted during batch record review. there were no confirmed out-of-specification stability deviations and no unusual trends were observed for the stability results of the stability batches tested during the review period of this annual product quality review (apqr).Environmental control: the following items were checked as part of the investigation by environmental control: total number of environmental monitoring samples collected during filling: 1) viables: incorporation room (07/040): (b)(6) 2022 ¿ (b)(6) 2022.26 samples for active air, passive air and surfaces.34 samples for personnel (gloves and gown).Filling (room 07/179) (b)(6) 2022 ¿ (b)(6) 2022.50 samples for active air, passive air and surfaces.75 sample for personnel (gloves and gown).2) non-viable particles: incorporation and filling: continuous sampling in class a and b background a.Trends analysis for the filling suite: no negative trends identified for both the incorporation room and the filling room.Conclusion: there were no deviations for environmental control.All results were conforming.In addition, there were no negative trends.Aseptic processes: all relevant aseptic processes and equipment are in requalified status.Release & sterilization cycles: -discovisc batch vd822a was released without any deviations.All related qc-testing (including sterility, lal, particles, animal testing) results were conforming.-the batch was sterilized in cycle 03115016 (sterigenics petit rechain ¿ st7) in three 3 carts; all carts of the cycle were conforming.- in the same cycle, carts of two other batches were sterilized, and both were also free from deviations.As no manufacturing related issues were identified, , and no complaint sample was received, no manufacturing related root cause was identified.All batches are released according to the required specifications.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.As no manufacturing related issues were identified, no manufacturing related root cause was identified.Therefore, no action is initiated.Manufacturer will continue to monitor for evidence of adverse trending of reported events and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|