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001 ocn319539400;

003 OCoLC;

005 20090803150137.0;

006 m d f ;

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

008 090428s2008 mdu o f000 0 eng d;

040 a| GPOc| GPOd| MvI;

049 a| ERE#;

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

086 0 a| HE 20.4802:C 76;

245 00 a| Guidance for industry :b| container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.;

246 30 a| Container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products;

260 a| Rockville, MD :b| U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicinec| [2008];

300 a| i, 6 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 CBER Web site. Address as of 4/28/09: http://www.fda.gov/cber/gdlns/contain.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on Apr. 28, 2009).;

500 a| "February 2008.";

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

650 0 a| Containersx| Testing.=| ^A97314;

650 0 a| Caps and closuresz| United Statesx| Testing.=| ^A1000329;

650 0 a| Biologicalsz| United States.=| ^A652521;

650 0 a| Drugsz| United States.=| ^A640;

650 0 a| Medical instruments and apparatusz| United States.=| ^A3247;

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

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

710 2 a| Center for Devices and Radiological Health (U.S.)=| ^A119573;

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

856 40 u| https://purl.fdlp.gov/GPO/LPS111964;

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

596 a| 1;

998 a| 1898622;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1898622-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/14/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.

Format	Electronic
Publication Info	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine [2008]
Description	i, 6 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS111964
Subjects	Containers--Testing. Caps and closures--United States. --Testing. Biologicals--United States. Drugs--United States. Medical instruments and apparatus--United States.

Other author/creator	Center for Biologics Evaluation and Research (U.S.)
Other author/creator	Center for Drug Evaluation and Research (U.S.)
Other author/creator	Center for Devices and Radiological Health (U.S.)
Other author/creator	Center for Veterinary Medicine (U.S.)
Portion of title	Container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
General note	Title from PDF title page (viewed on Apr. 28, 2009).
General note	"February 2008."
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical details	Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://www.fda.gov/cber/gdlns/contain.pdf ; current access is available via PURL.
GPO item number	0499-T-02 (online)
Govt. docs number	HE 20.4802:C 76

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Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.

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