21 C.F.R. § 211.160

General requirements

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(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified.

(b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include:

(1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration.

(2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified.

(3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. Such samples shall be representative and properly identified.

(4) The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]

Notes of Decisions

Cited in 4 cases (3 in the last 5 years), 1988–2025 · leading case: John D. Copanos & Sons, Inc. & Kanasco, Ltd. v. Food & Drug Admin. & Frank E. Young, M.D., ph.d., Comm'r of Food & Drugs, 854 F.2d 510 (D.C. Cir. 1988).

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John D. Copanos & Sons, Inc. & Kanasco, Ltd. v. Food & Drug Admin. & Frank E. Young, M.D., ph.d., Comm'r of Food & Drugs, 854 F.2d 510 (D.C. Cir. 1988). “at 29280; 21 C.F.R. § 211.160 (b)(4) (requiring the calibration of laboratory equipment “at suitable intervals in accordance with an established written program”); see also id.”

Pfizer Inc. & Tris Pharma, Inc. v. the State of Texas & Tarik Ahmed (Tex. App. 2025). · cites it 2× “48, 49, 52 Other Authorities 21 C.F.R. § 211.160 .....................”

Navarro v. Walgreens Boots All., Inc. (E.D. Cal. 2025). · cites it 2× “” 21 C.F.R. § 211.160 . “Laboratory records shall include complete data 24 derived from all tests necessary to assure compliance with established specifications and 25 standards, including examinations and assays” and a “statement of the results of tests and how 26 the results…”

Pineda v. Lake Consum. Prods., Inc. (E.D. Pa. 2025). “¶ 25 (citing to 21 C.F.R. § 211.160 ), and laboratory records that include “data derived from all tests necessary to assure compliance with established specifications and standards,” and a “statement of the results of tests and how the results compare with established standards…”

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