21 CFR Part 213
PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
- PART 213—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter C—Drugs: General
- Subpart A—General Provisions
- § 213.1 Scope.
- § 213.3 Definitions.
- Subpart B—Organization and Personnel
- § 213.22 Responsibilities of quality unit.
- § 213.25 Personnel qualifications and responsibilities.
- § 213.34 Consultants.
- Subpart C—Buildings and Facilities
- § 213.42 Design and construction features.
- Subpart D—Equipment
- § 213.63 Equipment design, size, and location.
- § 213.65 Equipment construction.
- § 213.67 Equipment maintenance and cleaning.
- § 213.68 Automatic, mechanical, and electronic equipment.
- Subpart E—Control of Incoming Designated Medical Gas, Components, and Medical Gas Containers and Closures
- § 213.80 General requirements.
- § 213.82 Receipt and storage of incoming designated medical gases.
- § 213.84 Testing and approval or rejection of components, containers, and closures.
- § 213.89 Rejected components, incoming designated medical gases, and medical gas containers and closures.
- § 213.94 Medical gas containers and closures.
- Subpart F—Production and Process Controls
- § 213.100 Written procedures; deviations.
- § 213.101 Charge-in of components and incoming designated medical gases.
- § 213.110 Sampling and testing of in-process materials.
- Subpart G—Packaging and Labeling Control
- § 213.122 Materials examination and usage criteria.
- § 213.125 Labeling issuance.
- § 213.130 Packaging and labeling operations.
- Subpart H—Holding and Distribution
- § 213.150 Warehousing and distribution procedures.
- Subpart I—Laboratory Controls
- § 213.160 General requirements.
- § 213.165 Testing and release for distribution.
- § 213.166 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.
- Subpart J—Records
- § 213.180 General requirements.
- § 213.182 Equipment cleaning and use log.
- § 213.184 Records for components, medical gas containers and closures, and labeling.
- § 213.186 Master production and control records.
- § 213.189 Batch production and control records.
- § 213.192 Production record review.
- § 213.194 Laboratory records.
- § 213.196 Distribution records.
- § 213.198 Complaint files.
- Subpart K—Returned and Salvaged Medical Gases
- § 213.204 Returned medical gases.
- § 213.208 Salvaging of medical gases.
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