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

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.

Latest Forms, Documents, and Supporting Material

Document Name
Recordkeeping CGMP for Finished Pharmaceuticals
Requests for Dispute Resolution (Tier One and Tier Two) Other-Agency Guidance
Pharmaceutical Voluntary Consensus Standard Recognition Other-Agency Guidance
Recordkeeping CGMP APIs
Recordkeeping CGMP for Medical Gases, Containers, and Closures Other-Agency Guidance

All Historical Document Collections

202309-0910-010 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-09-28
202304-0910-008 Approved without change	Revision of a currently approved collection	2023-04-26
202105-0910-004 Approved without change	Extension without change of a currently approved collection	2021-06-23
201804-0910-009 Approved without change	Revision of a currently approved collection	2018-04-16
201502-0910-014 Approved without change	Extension without change of a currently approved collection	2015-03-06
201109-0910-005 Approved without change	Extension without change of a currently approved collection	2011-09-29
200809-0910-008 Approved without change	Extension without change of a currently approved collection	2008-09-30
200512-0910-009 Approved without change	No material or nonsubstantive change to a currently approved collection	2005-12-22
200507-0910-005 Approved without change	Extension without change of a currently approved collection	2005-07-27
200206-0910-003 Approved without change	Extension without change of a currently approved collection	2002-06-11
199904-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1999-04-22
199509-0910-006 Approved without change	No material or nonsubstantive change to a currently approved collection	1995-09-30
199209-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1992-09-15
198801-0910-003 Approved without change	Reinstatement with change of a previously approved collection	1988-01-04
198502-0910-004 Approved without change	Revision of a currently approved collection	1985-02-12
198309-0910-002 Approved with change	No material or nonsubstantive change to a currently approved collection	1983-09-08
198212-0910-004 Approved without change	Revision of a currently approved collection	1982-12-29
198207-0910-006 Approved with change	No material or nonsubstantive change to a currently approved collection	1982-07-16
198110-0910-003 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