Regulation Text
(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
Authority
21 U.S.C. 321,351,352,355,360b,360ddd,360ddd-1,371,374;42 U.S.C. 216,262,263a,264.
Related Guidelines (3)
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations (Status: Draft)
→Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry (Status: Final)
→Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry (Status: Final)
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