Handling results

Filling of parenteral product is taking place in Class 100 .After 7 days of incubation of settle plate and air samples of filling area,observed count exceeding action limit.
Is this deviation or OOS?
After investigation,no cause or any breach of aseptic practices found.
How is this to be documented?
What is the fate of batch that was under filling when results were out of limit?

Warm Regards
Ravindra Upare

Obiviously this Triggers an OOS.
The OOS investigation shall initiate from Laboratory, Personnel, Manufacturing area & further shall subject to the root cause analysis. Once the root cause has been identified, the impact assesment has to be justified for the further decision of the product which was under filling.

Investigation concludes that nothing abnormal/untoward happen.
Now my Q is How this OOS is to be closed?

just prepare an impact assesment & close the OOS.


You can use investigation tools like fish bone diagram for investigation purpose and there by you can identify the most probable cause for this failure and can take corrective action for the same.
Any failure in the manufactuirng process indicates there is a need of improvement.Even you could not able to find out the exact root cause, you can go with corrective action with the help of identified cause and there by close the oos.