Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases

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 Practices for Finished Pharmaceuticals and Medical Gases expires 2021-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0139 SSA Finished Pharmaceuticals 2018 Ext.pdf Supporting Statement A
Recordkeeping CGMP for Finished Pharmaceuticals
Returned Drug Products
Compliant Files
Distribution Records
Laboratory Records
Discrepancies in Drug Product Production and Control Records
Batch Production and Control Records
Master Production and Control Records
Component, Drug, Product Container, Closure, and Labeling Records
Equipment Cleaning and Use Log
Procedures for Notification of Regulatory Actions
Production, Control, and Distribution Records
Laboratory Animals
Stability Testing
Test Methodology
Laboratory Controls
Expiration Dating
Tamper-Evident Packaging
Tamper Evident-Packaging
Labeling and Packaging Facilities
Labeling and Packaging Material
Equipment Identification
Production and Process Controls
Components and Drug Product Containers or Closures
Filters
Computer or Related Systems
Automatic, Mechanical, and Electronic Equipment
Changes in Master Production and Control Records or Other Records
Equipment Cleaning and Maintenance
Consultants
Recordkeeping CGMP for Medical Gases, Containers, and Closures Other-Agency Guidance

All Historical Document Collections

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