21 C.F.R. § 211.67

Equipment cleaning and maintenance

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(a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:

(1) Assignment of responsibility for cleaning and maintaining equipment;

(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;

(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;

(4) Removal or obliteration of previous batch identification;

(5) Protection of clean equipment from contamination prior to use;

(6) Inspection of equipment for cleanliness immediately before use.

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008]

Notes of Decisions

Cited in 5 cases, 1988–2010 · leading case: In re Digitek® Product Liability Litigation

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In re Digitek® Product Liability Litigation (2010) wvsd “[ 21 CFR § 211.67 (b)] For example: a) Cleaning validation was performed for the process trains without evaluating for sample recovery for numerous products, including: .”

John D. Copanos and Sons, Inc. And Kanasco, Ltd. v. Food and Drug Administration and Frank E. Young, M.D., ph.d., Commis (1988) cadc “, 21 C.F.R. § 211.67 (equipment and utensils to be cleaned, maintained, and sanitized at “appropriate intervals”); id.”

Crocker v. KV PHARMACEUTICAL CO. (2010) moed “Failure to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product, as required by 21 C.F.R. § 211.67 (a); and g.”

United States v. Barr Laboratories, Inc. (1993) njd “…and 211.182 [equipment cleaning and use log]. 21 C.F.R. § 211.67 . 140. Repeated FDA criticism of Barr’s failure to validate its cleaning procedures leads the Government to challenge Barr’s compliance with this section of the regulations. Barr points to its cleaning…”

Public Pension Fund Group v. Kv Pharmaceutical Co. (2010) moed “Failure to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product, as required by 21 C.F.R. § 211.67 (a); and G.”

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