Sir in one of the probable root cause you mentioned presence of water droplets on sampler - If this is the case, wouldn't it be considered as inadequate sterilization cycle?
We are talking of in process bulk sample where sample containers are required to be cleaned for chemical analysis and if bottle not dried properly then can lead to problems in assay For bio burden, we need sterile containers
Sir....First of all inprocess results should be considered as reference purpose only and should not not be apply specification critera The reason behind not Considering the result is due to in process means incomplete process and further reaction shall happen to make the perfect product. Even FDA guiidelines never speak about in process oos results it says finished product results only as finished the manufacturing In those cases we need to take incident and understand the issue to avoid recurrence
In pharma we can do anything.. Until justify... But never do testing for compliance the results nevertheless can do for compliance for actually what happened.
Nice information sir,
And please make a vedio on contamination control strategy (CCS) as per EU
Sir in one of the probable root cause you mentioned presence of water droplets on sampler - If this is the case, wouldn't it be considered as inadequate sterilization cycle?
We are talking of in process bulk sample where sample containers are required to be cleaned for chemical analysis and if bottle not dried properly then can lead to problems in assay
For bio burden, we need sterile containers
Sir....First of all inprocess results should be considered as reference purpose only and should not not be apply specification critera
The reason behind not Considering the result is due to in process means incomplete process and further reaction shall happen to make the perfect product.
Even FDA guiidelines never speak about in process oos results it says finished product results only as finished the manufacturing
In those cases we need to take incident and understand the issue to avoid recurrence
Hi sir if Inprocess is not available, however FP results are passing then how to investigate to release a batch.
Sir can we Take Duplicate samples (additional sample) for all inprocess sampling of bulk ( I. e: Asaay & Sterility)
Yes if you want to have backup samples, it should be part of protocol and batch record.
In pharma we can do anything.. Until justify... But never do testing for compliance the results nevertheless can do for compliance for actually what happened.