21 CFR 211.113 - Control of microbiological contamination.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart F [§ 211.100 - § 211.115]

§ 211.113 - Control of microbiological contamination.

(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]

authority: 21 U.S.C. 321,351,352,355,360b,371,374; 42 U.S.C. 216,262,263a,264

source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

cite as: 21 CFR 211.113