Deviation 079/2022 – Annex 1
Investigation:
Was verified that for the batches of DS F125/10 #21074 the result of bioburden on
SDA plate was 24 CFU/ml (mean) at t=12 months. The result out of specification
resulted in the OOS #035/2022.
DS F125/10 batch #21074 was placed in stability study in October of 2021 and for
the time points t1, t3, t6, t9 all test results wer4e within specification, namely,
appearance, phage titer and microbiology. Therefore, the product history evidences
a profile of microbial limit stable and within specification of (≤ 100 CFU/mL TAMC, ≤
10 CFU/mL TYMC).
An OOS investigation was initiated at 26th of October 2022. No laboratory error was
identified thereupon was decided to proceed with a retest of a new sample of the
batch by a different operator. The results the bioburden retest also evidenced OOS
result, precisely a medium result of 37 CFU/ml (SDA plate).
It is important to not that the results for TAMC were within specification at t=12
months, and in the previous stability sampling points.
Initially batches were placed in stability studies considering one vial, however, was
ascertained that it is not a good laboratory practice to perform stability studies
placing one vial of product for the different stability sampling points. It was decided
to place several vials of the same product/same batch, either DS or DP for the
different stability sampling points, therefore accounting, and avoiding possible
contaminations and insufficient amount of product to perform the required tests.
Root cause:
Possible cross contamination of the batch placed in stability study during the last
sampling point.
Impact on final product, material, process, equipment, or data?
No impact on the stability evaluation of the batch, data of product demonstrates a
stable profile for all tests over 9 months. The stability study of the batch was closed
and considered conclude after the time point of t= 12 months.