§ 211.160 General requirements.
Cited in 1 FDA warning letterHow BatchGlow handles this
(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]
Cited in FDA warning letters
1 of the 6 FDA warning letters in this collection (2023–2026, cosmetic and OTC manufacturers) cite this section as a violation.
- Woodbine Products Company Inc. · 27 Jul 2026
violation 3: 21 CFR 211.160(b)
How BatchGlow handles this
Results are entered against the item's specification and its limits, QA cannot approve a formula whose bulk item has no test assigned, and scales are checked with calibrated test weights.
What it asks for, in plain words
- 21 CFR 211.160
- Specifications, standards, sampling plans and test procedures are drafted by the responsible unit and approved by the quality control unit, followed and documented at the time, with deviations recorded and justified. Laboratory controls are scientifically sound and cover testing of incoming lots, of in-process materials and of finished products, and calibration of instruments.
- 21 CFR 211.160(b)(4)
- Instruments, apparatus, gauges and recording devices are calibrated at suitable intervals under a written program with directions, schedules, accuracy and precision limits and remedial action. One that does not meet its specifications is not used.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.