21 CFR Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals: Subpart F - Production and Process Controls
Sec. 211.113 (a) & (b) 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.
Sec. 211.113 (a) & (b) Control of microbiological contamination: