21 C.F.R. § 211.113

Current through April 30, 2024
Section 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.

21 C.F.R. §211.113

43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008