http://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments.aspxCopyright 2008en-usFri, 30 Jul 2010 23:38:59 GMT1http://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2010-PDA-Comments-on-EU-GMP-Annex-2-Manufacture-of-Biological-Medicinal-Substances-and-Products-.aspxPDA is pleased to provide comments on the latest revision of the EU GMP Annex 2.Mon, 26 Jul 2010 12:39:42 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2010-PDA-Comments-to-the-EU-Guidelines-to-GMP-Part-1-Medicinal-Products-for-Human-and-Veterinary.aspxPDA is pleased to provide comments on the revised Chapter 2 of the EU GMP, originating November 18, 2009.Wed, 02 Jun 2010 09:27:43 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2010-PDA-Comments-to-the-EU-Guidelines-to-GMP-Part-I-Medicinal-Products-for-Human-and-Veterinary-.aspxPDA is pleased to provide comments on the revised Chapter 1 of the EU GMP, originating from November 18, 2009.Wed, 02 Jun 2010 09:24:26 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2009-PDA-Comments-to-Concept-Paper-on-the-Revision-of-the-EU-Guideline-on-GDP.aspxPDA is pleased to offer comments on the concept paper pertaining to the revision of the European Guideline on Good Distribution Practices (GDP)Wed, 05 May 2010 12:29:18 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-the-Concept-Paper-for-Implementation-of-ICHQ10.aspxPDA is pleased to provide comments on the Concept Paper for the Implementation of ICH Q10 in the European GMP Guide.Wed, 05 May 2010 12:19:09 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-FDAs-Request-for-Comments-on-the-Transparency-Task-Force.aspxPDA is pleased to respond to the FDA's request for comments on the Transparency Task Force.Thu, 15 Apr 2010 12:32:27 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2010-PDA-Comments-on-Explanatory-Notes-for-Pharmaceutical-Manufacturers-on-the-Preparation-of-a-S.aspxPDA is pleased to offer comments on the Note for Guidance on Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File and Content of a Site Master File, ENTR/F2/MT/AM/JR d (2009), 10 December 2009Tue, 30 Mar 2010 11:30:23 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2010-PDA-Comments-on-Planning-for-the-Effects-of-High-Absenteeism-to-Ensure-Availability-of-Medica.aspxPDA is pleased to offer comments on the draft Guidance for Industry, "Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products."Fri, 05 Mar 2010 10:07:51 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2010-PDA-Comments-on-Current-Good-Manufacturing-Practice-Requirements-for-Combination-Products.aspxPDA is pleased to offer comments on the prposed rule under 21 CFR Part 4, Docket No. FDA-2009-N-0435-0004 in the matter of "Current Good Manufacturing Requirements for Combination Products, f/k/a Docket No. FDA-2008-D-0409. Thu, 18 Feb 2010 09:36:14 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-Postmarketing-Safety-Reporting-for-Combination-Products-FDA-2008-N-0424.aspxPDA is pleased to offer comments on the proposed rule under 21 CFR Part 4, "Postmarketing Safety Reporting for Combination Products."Thu, 04 Feb 2010 13:36:41 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-Recommendations-for-the-Evaluation-of-Animal-Cell-Cultures-as-Substrates-for-the-Man.aspxN/ATue, 29 Sep 2009 10:23:44 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/FDA-Comments-on-Federal-Docket-Management-System-Docket-FDA-2009-D-0179.aspxPDA comments on the Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products.Wed, 29 Jul 2009 09:34:49 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2009-PDA-Comments-on-the-Revised-TSE-Note-for-Guidance.aspxPDA comments on the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (Doc. Ref. EMEA/410/10/01 -- Rev. 4, 21 February 2008Tue, 30 Jun 2009 14:39:16 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2009-PDA-Comments-on-Securing-the-Drug-Supply-Chain.aspxPDA comments on the Draft Guidance for Industry on Standards for Securing the Drug Supply chain -- Standardized Numerical Indentification for Prescription Drug PackagesWed, 15 Apr 2009 15:10:37 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2009-PDA-Comments-to-EDQM-Pharmaeuropa-Chapter-XXXX2031.aspxPDA comments to EDQM on Pharmaeuropa Volume 21, No. 1, January 2009, proposed revisions to Chapter XXXX:2031, "Monoclonal Antibodies for Human Use."Mon, 06 Apr 2009 09:24:55 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2009-PDA-Comments-to-EDQM-on-Pharmaeuropa-Chapters-2616-and-523.aspxPDA comments on Pharmaeuropa Volume 21, No. 1, January 2009 on Proposed Revisions to Chapter 2.6.16, "Test for Extraneous Agents in Biological Products," and Chapter 5.2.3, "Cell Substrates for the Production of Biological Products."Mon, 06 Apr 2009 09:21:10 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2009-PDA-Comments-on-the-Process-Validation-Guidance.aspxPDA's official comments along with verbatim comments made by PDA members on the Draft Guidance for Industry on Process Validation: General Principles and Practices. Verbatim comments submitted by PDA Members have not been approved by the PDA Regulatory Affairs and Quality Committee or the PDA Board of Directors. They do not reflect official PDA comments. They are provided for educational proposes only. Fri, 20 Mar 2009 12:38:49 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-EU-Guidelines-to-GMP-Medicinal-Products-for-Human-and-Veterinary-Use-Draft-Annex-1.aspxPDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use, Draft Annex 13, Manufacture of Investigational Medicinal ProductsThu, 29 Jan 2009 10:37:48 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Commentary-on-Draft-Guidance-on-Potency-Testing-of-Cellular-and-Gene-Therapy-Products-Submitted.aspxPDA comments on Draft Guidance for Industry on Potency Testing of Cellular and Gene Therapy Products Mon, 12 Jan 2009 14:28:45 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-Draft-Guidance-for-Parametric-Release.aspxPDA comments on the Draft Guidance for Industry on Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat ProcessesFri, 06 Mar 2009 16:10:46 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2008.aspxN/AFri, 11 Jul 2008 09:36:02 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-EU-Guidelines-to-GMP-Draft-Annex-11-Computerised-Systems.aspxPDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary Use, Draft Annex 11, Computerized SystemsThu, 15 Jan 2009 10:22:00 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDA-Comments-on-EU-Guidelines-to-GMP-Chapter-4.aspxPDA comments on the Draft Guidance EU Guidelines to GMP, Medicinal Products for Human and Veterinary UseWed, 14 Jan 2009 09:31:07 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/PDACommentsonICHQ8.aspxPDA comments on the Draft Guidance ICH Q8 Annex, Pharmaceutical DevelopmentMon, 15 Sep 2008 12:34:58 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/annex2pdacvrltrcommenttblfinal.aspxPDA Comments on GMP Draft Annex 2: Manufacture of Biological Medicinal Product for Human UseFri, 11 Jul 2008 09:36:12 GMT/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryAffairsandQualityCommitteRAQC.aspxN/ASun, 07 Sep 2008 14:38:27 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/pdacommentsonproposedchangestogmpscommentgrid.aspxPDA Comments on Proposed Changes to Drug Product GMPs for Finished Pharmaceuticals Fri, 11 Jul 2008 09:36:35 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/draftguidanceq4bannexiiicvrltcommentary.aspxPDA Comments on Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3 on Test Particulate Contamination: Subvisible Particles General ChapterFri, 11 Jul 2008 09:36:16 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/RAQCInfo2.aspxN/AFri, 11 Jul 2008 09:23:43 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/RAQCInfo2/may2withdrawaldirectfinalrule.aspxN/AFri, 11 Jul 2008 09:37:58 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/RAQCInfo2/gmpannex1submissionlettertotheemea.aspxN/AFri, 11 Jul 2008 09:37:54 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/RAQCInfo2/annex1commentsubmissiondocumenttotheemea.aspxN/AFri, 11 Jul 2008 09:37:50 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/RAQCInfo2/PDFs.aspxN/AFri, 11 Jul 2008 09:26:14 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/RAQCInfo2/miscdocs.aspxN/AFri, 11 Jul 2008 09:23:45 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/comments.aspxN/AFri, 11 Jul 2008 09:36:07 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/comments/RegulatoryCommentsArchive.aspxN/AMon, 11 Aug 2008 16:52:58 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/comments/minutesraqcjanuary2008.aspxN/AFri, 11 Jul 2008 09:36:31 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/comments/2008meetingdates.aspxN/AFri, 11 Jul 2008 09:36:26 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/comments/raqcminutesfebruary282008.aspxN/AFri, 11 Jul 2008 09:36:50 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/comments/RegulatoryComments2007.aspxN/AMon, 11 Aug 2008 17:32:48 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007.aspxN/AFri, 11 Jul 2008 09:34:35 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/pdacvrltrtableemeamabfinal29nov07.aspxN/AFri, 11 Jul 2008 09:43:14 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/ichq10coverletter100907.aspxCover Letter to the FDA, October 9, 2007Fri, 11 Jul 2008 09:35:06 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/ichq10commentgridfinal2.aspxN/AFri, 11 Jul 2008 09:35:11 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/cvrltrproposedchangescanadiangmpregs.aspxProposal Letter to HPFD from PDAFri, 11 Jul 2008 09:34:52 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/draftcommentstohealthcanada21907.aspxPDA Recommendation and Rational Regarding the Proposal for Revisions to Canadian GMPs Fri, 11 Jul 2008 09:34:56 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/pdacommentsimpbatchreleasecertificate.aspxN/AFri, 11 Jul 2008 09:35:26 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/finalpdalettercommentschapter1.aspxN/AFri, 11 Jul 2008 09:35:01 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2007/Final_PDA_LetterComments_Chapter_1.aspxFinal_PDA_LetterComments_Chapter_1.pdfSat, 20 Sep 2008 10:56:00 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006.aspxN/AFri, 11 Jul 2008 09:33:09 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/2007annex1commentsubmissiondocumenttotheemea.aspxN/AThu, 10 Jul 2008 11:23:10 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/emeachmpbwpgrid1307.aspxSubmission Comments on Safety Evaluation of Biotechnological Investigational Medicinal Products Guidance Thu, 10 Jul 2008 13:07:33 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/cellsubtratesletter1307.aspxCover Letter to the U.S. FDA, Dec. 21, 2006 Thu, 10 Jul 2008 13:07:30 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/cellsubrtratesgrid1307.aspxSubmission Comments on Biological Starting Materials GuidanceThu, 10 Jul 2008 13:07:27 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/fdacoverletterdirectandfinalrule04032006.aspxN/AFri, 11 Jul 2008 09:33:41 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/vsbiotechimpsletter1307.aspxCover Letter to the EMEA, Dec. 28, 2006Thu, 10 Jul 2008 13:07:42 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/annex1.aspxCover Letter to the EMEA, April 24, 2006 Thu, 10 Jul 2008 13:29:47 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/200605submissioncommentsannex1summaryapril242006.aspxPDA Comments on EMEA's Annex 1Thu, 10 Jul 2008 13:28:33 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/200605annex1pdaversionfinal.aspxPDA Suggested Text for Annex 1 Thu, 10 Jul 2008 13:28:27 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/2006cvrletterdraftguidanceindsmarch172006.aspxN/AThu, 10 Jul 2008 13:28:45 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/draftcommentgridraqcapprovalforphase1gmpguidance.aspxExcel SpreadsheetFri, 11 Jul 2008 09:24:01 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2006/2006fdacoverletterdirectandfinalrule04032006.aspxN/AThu, 10 Jul 2008 13:28:48 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2005.aspxN/AFri, 11 Jul 2008 09:29:06 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2005/2005uspproposalbodapproval123005.aspxN/AThu, 10 Jul 2008 13:07:24 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2005/midwestchptcommentsichq9cvrltr.aspxCover LetterThu, 10 Jul 2008 13:07:36 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2005/submissionfinalpdacommentsichq9083105.aspxFinal Comments Grid (Excel Spreadsheet)Thu, 10 Jul 2008 13:07:39 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2005/2005docket2005d0021dup.aspxDocket No. 2005D-0021Thu, 10 Jul 2008 13:07:21 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004.aspxN/AFri, 11 Jul 2008 09:26:24 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/whoagendapharmaceuticalcommitteemtgoctober2004.aspxN/AFri, 11 Jul 2008 09:29:02 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/viralsafetyevaluationofbiotechproductstobeusedinclintrials.aspxN/AFri, 11 Jul 2008 09:28:59 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09:28:34 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/ichs8step2.aspxN/AFri, 11 Jul 2008 09:28:30 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/ichq9.aspxN/AFri, 11 Jul 2008 09:28:26 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/ichq9draft3102804.aspxN/AFri, 11 Jul 2008 09:28:21 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/ichq8version310june2004.aspxN/AFri, 11 Jul 2008 09:28:17 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/ichq8pharmaceuticaldevelopmentstep2.aspxN/AFri, 11 Jul 2008 09:28:14 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/gmpoversightwillhavefdawidecoordinationunderrxqualitycouncil.aspxN/AFri, 11 Jul 2008 09:28:10 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/germanbiotechinspection.aspxN/AFri, 11 Jul 2008 09:28:07 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/finalraqcdocumentmanagementprocessoctober2004final.aspxN/AFri, 11 Jul 2008 09:28:03 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdavaccinelabel.aspxN/AFri, 11 Jul 2008 09:28:00 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdasupplementclaims.aspxN/AFri, 11 Jul 2008 09:27:56 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdaqualitysystemsguidancesuggeststrendingforbatchtesting.aspxN/AFri, 11 Jul 2008 09:27:53 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdaimprovesthesafetyofhumancellsandtissuesbyfinalizingnewrulesforgoodtissuepractice.aspxN/AFri, 11 Jul 2008 09:27:50 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdaguidanceonconsultantsandbiotechclinicals.aspxN/AFri, 11 Jul 2008 09:27:47 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdafeecomboprods.aspxN/AFri, 11 Jul 2008 09:27:43 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdadisputeresolutionmapp.aspxN/AFri, 11 Jul 2008 09:27:40 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdadietarysupplements.aspxN/AFri, 11 Jul 2008 09:27:37 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdadietarysupguidance.aspxN/AFri, 11 Jul 2008 09:27:33 GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2004/fdacreatesfournewdrugchemistrydivisionsforcmcevaluation.aspxN/AFri, 11 Jul 2008 09:27:30 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GMThttp://www.pda.org/MainMenuCategory/QualityRegulatoryAffairs/RegulatoryComments/2003/articlecgmpsintheproductionofclinicalsupplies.aspxN/AFri, 11 Jul 2008 09:26:20 GMT