Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)

OMB 0910-0139

OMB 0910-0139

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 Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients) expires 2021-06-30 and can be found here.

All Historical Document Collections
Extension without change of a currently approved collection 2021-06-23
Approved without change
Revision of a currently approved collection 2018-04-16
Approved without change
Extension without change of a currently approved collection 2015-03-06
Approved without change
Extension without change of a currently approved collection 2011-09-29
Approved without change
Extension without change of a currently approved collection 2008-09-30
Approved without change
No material or nonsubstantive change to a currently approved collection 2005-12-22
Approved without change
Extension without change of a currently approved collection 2005-07-27
Approved without change
Extension without change of a currently approved collection 2002-06-11
Approved without change
Reinstatement with change of a previously approved collection 1999-04-22
Approved without change
No material or nonsubstantive change to a currently approved collection 1995-09-30
Approved without change
Reinstatement with change of a previously approved collection 1992-09-15
Approved without change
Reinstatement with change of a previously approved collection 1988-01-04
Approved without change
Revision of a currently approved collection 1985-02-12
Approved with change
No material or nonsubstantive change to a currently approved collection 1983-09-08
Approved without change
Revision of a currently approved collection 1982-12-29
Approved with change
No material or nonsubstantive change to a currently approved collection 1982-07-16
Approved without change
New collection (Request for a new OMB Control Number) 1981-10-30
OMB Details

Recordkeeping CGMP for Finished Pharmaceuticals

Federal Enterprise Architecture: Health - Public Health Monitoring


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