(a) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where appropriate:
(1) Tablet or capsule weight variation;
(2) Disintegration time;
(3) Adequacy of mixing to assure uniformity and homogeneity;
(4) Dissolution time and rate;
(5) Clarity, completeness, or pH of solutions.
(6) Bioburden testing.
(b) Valid in-process specifications for such characteristics shall be consistent with drug product final specifications and shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate. Examination and testing of samples shall assure that the drug product and in-process material conform to specifications.
(c) In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality control unit, during the production process, e.g., at commencement or completion of significant phases or after storage for long periods.
(d) Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
Notes of Decisions
Supernus Pharm., Inc. v. TWi Pharm., Inc., 265 F. Supp. 3d 490 (D.N.J. 2017).
· cites it 2× “See 21 C.F.R. § 211.110 . These controls are required to ^assure batch- uniformity and integrity of drug products.”
Crocker v. Kv Pharm. Co., 782 F. Supp. 2d 760 (E.D. Mo. 2010).
“Failure to establish control procedures to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug market, as required by 21 C.F.R. § 211.110 (a); c. Failure to make…”
United States v. Jay Marcus, 82 F.3d 606 (4th Cir. 1996).
“See 21 C.F.R. § 211.110 (a)(4) (1995). 2 . When submitting an abbreviated new drug application seeking FDA approval to market a generic drug, an applicant must demonstrate, inter alia, that the drug formulation that it proposes to use is bioequivalent to the name-brand drug.”
Pub. Pension Fund Grp. v. Kv Pharm. Co., 705 F. Supp. 2d 1088 (E.D. Mo. 2010).
“Failure to establish control procedures to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug market, as required by 21 C.F.R. § 211.110 (a); C. Failure to make…”
In re Genentech, Inc., 367 F. Supp. 3d 1274 (N.D. Okla. 2019).
· cites it 2× “See also 21 C.F.R. § 211.110 (a)( ), (b) (referencing "in-process specifications" applicable to drug product "weight variation"); Ex.”
United States v. Marcus (4th Cir. 1996).
“See 21 C.F.R. § 211.110 (a)(4) (1995). 2 Marcus was not initially aware of the modification, but when he learned of it, he elected not to inform the FDA or to seek approval for the revision for fear that the FDA would consider the change to be significant and require additional…”
— 21 C.F.R. § 211.110(a) — 1 case
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