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001 ocn466172237;

003 OCoLC;

005 20091116161529.0;

006 m d f ;

007 cr a||||||||||;

008 091116s2006 mdu ob f000 0 eng d;

040 a| GPOc| GPOd| MvI;

049 a| ERE#;

074 a| 0499-T (online);

086 0 a| HE 20.4702:Q 1/2;

245 00 a| Guidance for industry :b| quality systems approach to pharmaceutical CGMP regulations.;

246 30 a| Quality systems approach to pharmaceutical CGMP regulations;

260 a| Rockville, MD :b| U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,c| [2006];

300 a| 1 online resource (28 p.);

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

500 a| "Center for Biologics Evaluation and Research (CBER).";

500 a| "Center for Veterinary Medicine (CVM).";

500 a| "Office of Regulatory Affairs (ORA).";

500 a| "Pharmaceutical CGMPs.";

500 a| "September 2006.";

500 a| GPO Cataloging Record Distribution Program (CRDP).;

504 a| Includes bibliographical references (p. 25-26).;

650 0 a| Quality of productsz| United States.=| ^A252513;

650 0 a| Drug developmentx| Government policyz| United States.=| ^A443888;

650 0 a| Risk managementz| United States.=| ^A160415;

710 2 a| Center for Drug Evaluation and Research (U.S.)=| ^A431016;

710 2 a| Center for Biologics Evaluation and Research (U.S.)=| ^A368272;

710 2 a| Center for Veterinary Medicine (U.S.)=| ^A429293;

710 1 a| United States.b| Food and Drug Administration.b| Office of Regulatory Affairs.=| ^A687747;

856 40 u| https://purl.fdlp.gov/GPO/LPS116599;

949 a| Click on web addressw| asish| joyner94;

596 a| 1;

998 a| 2154687;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 2154687-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 12/28/2009x| EDOCUMENTz| JERESOURCE;

Guidance for industry : quality systems approach to pharmaceutical CGMP regulations.

Format	Electronic
Publication Info	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2006]
Description	1 online resource (28 p.)
Supplemental Content	https://purl.fdlp.gov/GPO/LPS116599
Subjects	Quality of products--United States. Drug development--Government policy. --United States. Risk management--United States.

Other author/creator	Center for Drug Evaluation and Research (U.S.)
Other author/creator	Center for Biologics Evaluation and Research (U.S.)
Other author/creator	Center for Veterinary Medicine (U.S.)
Other author/creator	United States. Food and Drug Administration. Office of Regulatory Affairs.
Portion of title	Quality systems approach to pharmaceutical CGMP regulations
General note	"Center for Biologics Evaluation and Research (CBER)."
General note	"Center for Veterinary Medicine (CVM)."
General note	"Office of Regulatory Affairs (ORA)."
General note	"Pharmaceutical CGMPs."
General note	"September 2006."
General note	GPO Cataloging Record Distribution Program (CRDP).
Bibliography note	Includes bibliographical references (p. 25-26).
GPO item number	0499-T (online)
Govt. docs number	HE 20.4702:Q 1/2

Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Access Content Online	✔ Available

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