C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart F—Production and Process Controls

21 C.F.R. § 211.113

Control of microbiological contamination

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(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]
Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2022–2022 · leading case: Sinnathurai v. Novavax, Inc. (D. Maryland 2022).
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Sinnathurai v. Novavax, Inc. (D. Maryland 2022). “§ 73 (quoting 21 C.F.R. §§ 211.113 , 211.56(c)). V. False Statements and Material Omissions □ Plaintiffs have alleged in the Amended Complaint that in light of Novavax’s awareness of these manufacturing obstacles relating to contamination, purity and potency levels, scaling, and…”
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