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FEDERAL · 21 CFR

Part 213 — Current Good Manufacturing Practice for Medical Gases

36 sections · Title 21: Food and Drugs

§ 213.1Scope.
§ 213.3Definitions.
§ 213.22Responsibilities of quality unit.
§ 213.25Personnel qualifications and responsibilities.
§ 213.34Consultants.
§ 213.42Design and construction features.
§ 213.63Equipment design, size, and location.
§ 213.65Equipment construction.
§ 213.67Equipment maintenance and cleaning.
§ 213.68Automatic, mechanical, and electronic equipment.
§ 213.80General requirements.
§ 213.82Receipt and storage of incoming designated medical gases.
§ 213.84Testing and approval or rejection of components, containers, and closures.
§ 213.89Rejected components, incoming designated medical gases, and medical gas containers and closures.
§ 213.94Medical gas containers and closures.
§ 213.100Written procedures; deviations.
§ 213.101Charge-in of components and incoming designated medical gases.
§ 213.110Sampling and testing of in-process materials.
§ 213.122Materials examination and usage criteria.
§ 213.125Labeling issuance.
§ 213.130Packaging and labeling operations.
§ 213.150Warehousing and distribution procedures.
§ 213.160General requirements.
§ 213.165Testing and release for distribution.
§ 213.166Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act.
§ 213.180General requirements.
§ 213.182Equipment cleaning and use log.
§ 213.184Records for components, medical gas containers and closures, and labeling.
§ 213.186Master production and control records.
§ 213.189Batch production and control records.
§ 213.192Production record review.
§ 213.194Laboratory records.
§ 213.196Distribution records.
§ 213.198Complaint files.
§ 213.204Returned medical gases.
§ 213.208Salvaging of medical gases.