21 CFR 211.68
Automatic, mechanical, and electronic equipment
21 CFR 211.68 is the regulation titled “Automatic, mechanical, and electronic equipment” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 43 FDA warning letters have cited it.
- Letters citing it
- 43 since 2021
- Jan 1 to Oct 30, 2026
- 5 against 10 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 27 letters
- Closed out
- 7% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (41 of 43). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.68 most often, as written in the letters.
- 23 lettersYour firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b))
- 2 lettersYour firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv))
- 2 lettersYour firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of and to maintain adequate written records of calibration checks and inspections of…
The regulation
Read the text of 21 CFR 211.68 (eCFR, as of Sep 1, 2026)
(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.
(b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.
(c) Such automated equipment used for performance of operations addressed by §§ 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements included in those sections relating to the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section, and one person checks that the equipment properly performed the operation.
[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995; 73 FR 51932, Sept. 8, 2008]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.68.
- 21 CFR 211.22Responsibilities of quality control unit27 letters cite both
- 21 CFR 211.100Written procedures; deviations18 letters cite both
- 21 CFR 211.160General requirements16 letters cite both
- 21 CFR 211.192Production record review16 letters cite both
- 21 CFR 211.165Testing and release for distribution15 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures13 letters cite both
- 21 CFR 211.166Stability testing11 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance10 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.68 that FDA posted most recently.
- DrugsView Laboratorios Jaloma S.A. de C.V.over-the-counter (OTC) drug productsIssuedMay 22, 2026PostedJun 2, 2026
- DrugsView GC America, Inc.OTC drug productsIssuedMay 14, 2026PostedMay 26, 2026
- DrugsView IDO Pharm Co., Ltd.Finished pharmaceuticals including (b)(4) over-the-counter drug productsIssuedMay 4, 2026PostedMay 12, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.