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003 OCoLC;

005 20090324140449.0;

006 m d f ;

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

008 090324s2008 mdu ob f000 0 eng d;

040 a| GPOc| GPOd| MvI;

049 a| ERE#;

074 a| 0499-T-02 (online);

086 0 a| HE 20.4802:P 49/6;

245 00 a| Guidance for industry :b| process validation, general principles and practices.;

246 30 a| Process validation, general principles and practices;

300 a| [20] p. :b| digital, PDF file;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

538 a| Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on Mar. 24, 2009).;

500 a| "Draft guidance.";

500 a| "November 2008.";

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

504 a| Includes bibliographical references (p. [20]).;

650 0 a| Biologicalsx| Evaluation.=| ^A652521;

650 0 a| Drugsx| Testing.=| ^A4660;

650 0 a| Manufacturing processesx| Evaluation.=| ^A38746;

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;

856 40 u| https://purl.fdlp.gov/GPO/LPS110592;

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

596 a| 1;

998 a| 1542698;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| MQ2920053l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 5/1/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. 0;

Guidance for industry : process validation, general principles and practices.

Other author	Center for Drug Evaluation and Research (U.S.)
Other author	Center for Biologics Evaluation and Research (U.S.)
Other author	Center for Veterinary Medicine (U.S.)
Format	Electronic
Publication Info	Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER) : Center for Veterinary Medicine (CGMP), [2008]
Description	[20] p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS110592
Subjects	Biologicals--Evaluation. Drugs--Testing. Manufacturing processes--Evaluation.

Portion of title	Process validation, general principles and practices
General note	Title from PDF title page (viewed on Mar. 24, 2009).
General note	"Draft guidance."
General note	"November 2008."
General note	GPO Cataloging Record Distribution Program (CRDP).
Bibliography note	Includes bibliographical references (p. [20]).
Technical details	Mode of access: Internet at the FDA Web site. Address as of 3/24/09: http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf ; current access is available via PURL.
GPO item number	0499-T-02 (online)
Govt. docs number	HE 20.4802:P 49/6

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Guidance for industry : process validation, general principles and practices.

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