No. 21 CFR 211.113(a) demands suitable created techniques to get proven and followed through manufacturing to circumvent objectionable microorganisms in drug goods not needed to be sterile. Additionally, the next paragraph of USP Common Chapter Antimicrobial Performance Screening reads: Antimicrobial preservatives should not be applied in
The inspection team is predicted for being delicate to this concern and make the observations in a very method that should develop the minimum amount of disruption in the conventional functioning environment. Yet, these types of fears will not be sufficient trigger for you to suspend this part of the inspection.The item complies Using the test, if
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