This information collection supports FDA regulations for finished pharmaceuticals, as well as medical gas containers and closures. The regulations mandate recordkeeping responsibilities that ensure covered articles are produced in accordance with current good manufacturing practice (CGMP). Products not in compliance with CGMP may be deemed adulterated and subject to agency enforcement action.
The latest form for Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases expires 2021-06-30 and can be found here.
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Supporting Statement A |
Federal Enterprise Architecture: Health - Public Health Monitoring