Title 21, Part 213 — Current Good Manufacturing Practice for Medical Gases

Scope.

Definitions.

Responsibilities of quality unit.

Personnel qualifications and responsibilities.

Consultants.

Design and construction features.

Equipment design, size, and location.

Equipment construction.

Equipment maintenance and cleaning.

Automatic, mechanical, and electronic equipment.

General requirements.

Receipt and storage of incoming designated medical gases.

Testing and approval or rejection of components, containers, and closures.

Rejected components, incoming designated medical gases, and medical gas containers and closures.

Medical gas containers and closures.

Written procedures; deviations.

Charge-in of components and incoming designated medical gases.

Sampling and testing of in-process materials.

Materials examination and usage criteria.

Labeling issuance.

Packaging and labeling operations.

Warehousing and distribution procedures.

General requirements.

Testing and release for distribution.

Stability 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.

General requirements.

Equipment cleaning and use log.

Records for components, medical gas containers and closures, and labeling.

Master production and control records.

Batch production and control records.

Production record review.

Laboratory records.

Distribution records.

Complaint files.

Returned medical gases.

Salvaging of medical gases.