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2010-09-23
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Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Rules and Regulations
D09002ee1bdd87bbf
D09002ee1bdd87c37
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards.
73 FR 51919
https://www.govinfo.gov/app/details/FR-2008-09-08/E8-20709
E8-20709
fr08se08-8
4160-01-S
Docket No. FDA-2007-N-0379
https://www.govinfo.gov/app/details/FR-2008-09-08/E8-20709
https://www.govinfo.gov/content/pkg/FR-2008-09-08/html/E8-20709.htm
https://www.govinfo.gov/content/pkg/FR-2008-09-08/pdf/E8-20709.pdf
Drugs
Packaging and Containers
Labeling
Laboratories
Prescription Drugs
Reporting and Recordkeeping Requirements
Warehouses
15 p.
51919
51933
73 FR 51919
Code of Federal Regulations
Title 21 Part 210
21 CFR Part 210
Code of Federal Regulations
Title 21 Part 211
21 CFR Part 211
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Federal Register Vol. 73, Issue
RULE
E8-20709
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2008-12-08
Docket No. FDA-2007-N-0379
4160-01-S
E8-20709
Final rule.
The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards.
This rule is effective December 8, 2008.
Mary Malarkey, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6190; or
Drugs
Packaging and Containers
Labeling
Laboratories
Prescription Drugs
Reporting and Recordkeeping Requirements
Warehouses
Amendments to Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals,
Federal Register
Vol. 73, no. 174
Office of the Federal Register, National Archives and Records Administration
2008-09-08
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281 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2008-09-08
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr08se08
https://www.govinfo.gov/app/details/FR-2008-09-08
https://www.govinfo.gov/content/pkg/FR-2008-09-08/pdf/FR-2008-09-08.pdf
https://www.govinfo.gov/content/pkg/FR-2008-09-08/xml/FR-2008-09-08.xml
fdlp
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DGPO
2010-09-23
2023-05-02
FR-2008-09-08
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FR
FR-2008-09-08
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