§ 211.113 Control of microbiological contamination.

Law · 21 CFR 211.113 · eCFR as of 25 Sep 2026 · checked 30 Sep 2026 · Official source: ecfr.gov

(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]