美国ICPE规定的主药和辅料的管理——David R. Schoneker.pptVIP

IPEC Activities and Excipient Regulation in the United States;Outline;What is IPEC?;What is IPEC?;Colorcon’s Involvement with IPEC;IPEC Mission;Building Bridges with Regulators ;Excipient GMPs in the U.S.;Excipient GMPs in the U.S.;IPEC Excipient GMP’s;IPEC Excipient GMP’s;Published IPEC-Americas Guidelines ;IPEC Initiatives;IPEC Initiatives;Current IPEA Audit Reports;Use of Excipients in NDA’s in the U.S.;Use of Excipients in NDA’s in the U.S.;U.S. Generic Applications;FDA’s Inactive Ingredient Database is available on-line: /scripts/cder/iig/index.cfm Database has certain limitations: In some cases, a quantitative limit is not shown in the public version due to confidentiality Often lists the same excipient by different names and sometimes uses trade names (multiple listings possible with different levels) The exact name used in the database must be known to search; a comprehensive list can not be retrieved Database is only updated quarterly;;Global COLORANT Regulations For Pharmaceuticals;One Color For The World: Global Formulation Problems;Key Colors Used In Global Pharmaceuticals;Desired Global Color Regulations;Drug Master Files;US DMF Facts (J. Clark, FDA, 2003);US DMF Filings, 2002 (J. Clark, FDA, 2003);Drug Master File Requirements ;Type IV DMF Information Requirements;IPEC Proposals: Global “Excipient Master Files”;Excipient Master Files: Consistent with CTD Submissions;Excipient Master File Components;EMF Organization;The Increasing Visibility of Excipients ;Qualification ofExcipient Suppliers;Supplier Qualification;IPEC Excipient Qualification Guideline;Excipient QualificationGuideline;? Copyright – IPEC Americas;Excipient QualificationProcess - User;? Copyright – IPEC Americas;Pharmacopeial Harmonization;;Harmonization of Excipient Standards;Today’s Harmonization Outcomes;Chinese Pharmacopeia;Product Filing InformationPre-Mixed Excipients;Product Filing InformationPre-mixed Excipients;;Drug Master FilesPre-mixed Excipients;Post-Approval Cha