No. 21 CFR 211.113(a) involves appropriate written methods for being set up and followed throughout manufacturing to prevent objectionable microorganisms in drug goods not needed to be sterile.   On top of that, the second paragraph of USP General Chapter Antimicrobial Success Screening

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As an example, take into account a pharmaceutical enterprise that depends on temperature-sensitive storage of vaccines. To make sure the vaccine is successful and Protected, the organization uses data loggers to observe and document temperature circumstances. Energetic calibration treatments don&