21 C.F.R. § 211.100
Written procedures; deviations
(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.
Notes of Decisions
Cited in 10
cases (5 in the last 5 years), 1993–2026 · leading case: Crocker v. KV PHARMACEUTICAL CO.
Crocker v. KV PHARMACEUTICAL CO. (2010)
“Failure to review and approve changes to written procedures by the quality control unit, as required by 21 C.F.R. § 211.100 (a); f. Failure to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety,…”
Public Pension Fund Group v. Kv Pharmaceutical Co. (2010)
“Failure to review and approve changes to written procedures by the quality control unit, as required by 21 C.F.R. § 211.100 (a); F. Failure to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety,…”
United States v. Barr Laboratories, Inc. (1993)
“” 21 C.F.R. § 211.100 . 74. These written procedures, in turn, must be verified.”
Shareholder Representative Services, LLC v. Alexion Pharmaceuticals, Inc. (2026)
“¶¶ 80–84 (describing Patheon’s manufacture process and concluding “Patheon failed to properly evaluate the differences between Suite #1 and Suite #2 and the impact the manufacturing differences may have had on product quality, in violation of cGMP requirements, per 21 CFR §§…”
Koshy v. Regeneron Pharmaceuticals, Inc. (2019)
“Plaintiff also appears to rely on 21 C.F.R. §§ 211.100 and 211.160. Those regulations mandate written change controls and contain general requirements for laboratory controls, respectively.”
Salzman v. ImmunityBio, Inc. (2024)
“(citing 21 C.F.R. § 211.100 ). 21 The FDA will not approve a biologic product if its production fails to comply with 22 the FDA’s minimum standards for drug manufacturing, otherwise known as current good 23 manufacturing practices (“cGMP”).”
Pfizer Inc. and Tris Pharma, Inc. v. the State of Texas and Tarik Ahmed (2025)
“21 CFR § 211.100 . 16 21 CFR § 211.22 (a).”
PINEDA v. LAKE CONSUMER PRODUCTS, INC. (2025)
“¶ 24 (citing to 21 C.F.R. § 211.100 ), “laboratory controls” must include “establishment of scientifically sound and appropriate specifications.”
Moussa Kouyate v. L. Perrigo Company, et al. (2026)
“Many of the cited cGMPs require manufacturers “to assure that the[ir] drug products have the identity, strength, quality, and purity they purport or are represented to possess,” 21 C.F.R. § 211.100 (a), or contain similar language.”
Mylan Pharmaceuticals, Inc. v. United Steel, Paper & Forestry, Rubber, Manufacturing, Energy, Allied Industrial & Servic (2008)
“21 C.F.R. § 211.100 (b). Mylan contends that Jones violated this GMP by manipulating the test results and, thus, failing to keep accurate records.”
— 21 C.F.R. § 211.100(a) — 1 case
Shareholder Representative Services, LLC v. Alexion Pharmaceuticals, Inc. (2026)
“¶¶ 80–84 (describing Patheon’s manufacture process and concluding “Patheon failed to properly evaluate the differences between Suite #1 and Suite #2 and the impact the manufacturing differences may have had on product quality, in violation of cGMP requirements, per 21 CFR §§…”
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