§ 211.113. Control of microbiological contamination.
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/us/cfr/t21/s§ 211.113·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.
(b)Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes. [43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
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§ 211.113
Control of microbiological contamination.
Fed. Reg.×3
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