StacksVerified U.S. regulatory reference

21 CFR §211.113

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.
  2. (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.