In our Microbiology lab
Ex: while doing MLT test for APi/sterile products
Suppose we will get out of specification/out of limit
Then what type of action will take
On observation of an OOS result in microbiological testing the microbiologist shall inform the same to section incharge.
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On observation on growth in sterility test media, record the results on the sterility test report and notify to the section incharge as well as QA.
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Check the quality of media used for testing i.e. GPT and GIT.
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Test the media containers for growth promotion test such as subculture from the container showing growth on SCDA plate and incubate at 30°c to 35°c.
Check the presence or absence of growth, if present then compare with in-house isolate, for conformation send the isolates for genetic identification. -
Carry out the laboratory investigation i.e. review the records of micro lab monitoring, cleaning of equipments, sterilisation of accessories used, PD of the area and Temp deta of the lab etc.
If reason identified take the corrective action. If no error is observed then phase 2 investigation shall be carried out i.e. manufacturing facility.
Evaluate the information gathered and assinable root cause for sterility failure can be determined.
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Thank you