(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as possible.
(b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.
(c) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling and the number of units per batch to be tested; such written procedure shall be followed.
(d) Acceptance criteria for the sampling and testing conducted by the quality control unit shall be adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels.
(e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2).
(f) Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed. Prior to acceptance and use, reprocessed material must meet appropriate standards, specifications, and any other relevant criteria.
Notes of Decisions
Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348 (Fed. Cir. 2012).
· cites it 7× “See 21 C.F.R. § 211.165 (a). This test must be done according to the patented methods de- scribed in an official compendium, in this case the United States Pharmacopeia (USP).”
The Medicines Co. v. Mylan, Inc., 853 F.3d 1296 (Fed. Cir. 2017).
· cites it 2× “1993); 21 C.F.R. § 211.165 (f). Between 2001 and 2005, Medicines and its contract manufacturer, Ben Venue Laboratories (“BVL”), produced and sold numerous batches of compounded bivalirudin having Asp9 levels of less than 1.”
United States v. Barr Labs., Inc., 812 F. Supp. 458 (D.N.J. 1993).
· cites it 2× “21 C.F.R. 211.165(a). And section 211.-165(f) specifies: Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected.”
Par Pharm., Inc. v. Eagle Pharm., Inc. (D. Del. 2021).
· cites it 2× “The parties agree, and I find, that the FDA’s definition of “release specification” is set forth in 21 C.F.R. § 211.165 . Section 211.165(a) provides that “Tflor each batch of [a] drug product, there shall be appropriate laboratory determination of satisfactory conformance to…”
Daugherty v. Padagis Israel Pharm. Ltd. (N.D. Cal. 2025).
· cites it 2× “FAC ¶ 68(i); see 21 C.F.R. § 211.165 (a). This cGMP regulation provides: 4 For each batch of drug product, there shall be appropriate 5 laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and 6 strength of…”
In re: MDL 2700 Genentech (10th Cir. 2020).
“” 21 C.F.R. § 211.165 (a). “Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected.”
In re Genentech, Inc., 367 F. Supp. 3d 1274 (N.D. Okla. 2019).
“21 C.F.R. § 211.165 (a). It also includes data from studies showing that the product meets prescribed requirements for safety, purity and potency; a full description of manufacturing methods; data establishing product stability; samples of the product, labeling, and containers;…”
— 21 C.F.R. § 211.165(a) — 1 case
United States v. Barr Labs., Inc., 812 F. Supp. 458 (D.N.J. 1993).
“21 C.F.R. 211.165(a). And section 211.-165(f) specifies: Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected.”
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