United States Government Publishing Office
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United States
National Archives and Records Administration
Office of the Federal Register
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FR
Regulatory Information
1995_register
executive
2010-09-25
article
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Amendment of Certain Requirements for Finished Pharmaceuticals
Rules and Regulations
D09002ee1be0678a9
D09002ee1be067978
United States
Department of Health and Human Services
originator
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 revising certain requirements of the current good manufacturing practice (CGMP) regulations for finished human and veterinary pharmaceuticals. The changes include clarifying the degree of discretion provided to manufacturers to determine whether separate or defined areas of production and storage are necessary, clarifying the standard used to determine the degree of scrutiny necessary to check the accuracy of the input to and output from computer systems, exempting investigational new drug products from bearing an expiration date, permitting the use of a representative sampling plan for the examination of reserve samples, and clarifying the manufacturer's responsibilities regarding batch records during the annual evaluation of drug product quality standards. These revisions will reduce regulatory burdens.
60 FR 4087
https://www.govinfo.gov/app/details/FR-1995-01-20/95-1361
95-1361
fr20ja95-11
RIN 0905-AA73
4160-01-F
Docket No. 90N-0376
https://www.govinfo.gov/app/details/FR-1995-01-20/95-1361
https://www.govinfo.gov/content/pkg/FR-1995-01-20/html/95-1361.htm
https://www.govinfo.gov/content/pkg/FR-1995-01-20/pdf/95-1361.pdf
5 p.
4087
4091
60 FR 4087
Code of Federal Regulations
Title 21 Part 211
21 CFR Part 211
Regulation Identification Number 0905-AA73
RIN 0905-AA73
Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Amendment of Certain Requirements for Finished Pharmaceuticals; Federal Register Vol. 60, Issue
RULE
95-1361
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 90N-0376
4160-01-F
95-1361
Final rule.
The Food and Drug Administration (FDA) is revising certain requirements of the current good manufacturing practice (CGMP) regulations for finished human and veterinary pharmaceuticals. The changes include clarifying the degree of discretion provided to manufacturers to determine whether separate or defined areas of production and storage are necessary, clarifying the standard used to determine the degree of scrutiny necessary to check the accuracy of the input to and output from computer systems, exempting investigational new drug products from bearing an expiration date, permitting the use of a representative sampling plan for the examination of reserve samples, and clarifying the manufacturer's responsibilities regarding batch records during the annual evaluation of drug product quality standards. These revisions will reduce regulatory burdens.
February 21, 1995.
Howard P. Muller, Jr., Center for Drug Evaluation and Research (HFD-362), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1046,
Federal Register
Vol. 60, no. 13
Office of the Federal Register, National Archives and Records Administration
1995-01-20
continuing
daily
deposited
born digital
310 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1995-01-20
P0b002ee180a894ef
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr20ja95
https://www.govinfo.gov/app/details/FR-1995-01-20
https://www.govinfo.gov/content/pkg/FR-1995-01-20/pdf/FR-1995-01-20.pdf
fdlp
4069
4370
DGPO
2010-09-25
2023-05-07
FR-1995-01-20
machine generated
eng
FR
FR-1995-01-20
60
13