No. 21 CFR 211.113(a) requires ideal composed treatments to get proven and followed all through manufacturing to circumvent objectionable microorganisms in drug items not needed to be sterile.   Also, the next paragraph of USP Standard Chapter Antimicrobial Efficiency Tests reads:  

Observe the temperature and relative humidity by way of respective Screen unit where ever mounted, use thermo hygrometer or temperature and RH sensor to examine temperature and RH in rooms/place. The installation records of the system really should deliver documented proof of all measured capacit

USFDA Warning letters are talked about, with analysis of essential deficiencies and observations, what can cause the observations, what you ought to have in position to meet agency expectations and prevent these kinds of observations and evets at your internet site, organization. “I fully g

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