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IPEC Excipient Master File

IPEC Excipient Master File: Outline. IPEC background and strategyFormat of the IPEC excipient master file guideStatus of guide and future plans . IPEC Excipient Master File Guide. Documents used as referenceICH Common Technical DocumentPhEur Certificate of Suitability ProcedureFDA Guideli

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IPEC Excipient Master File

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    1. IPEC Excipient Master File Christopher C. DeMerlis Manager, Regulatory Affairs Colorcon Division of Berwind Pharmaceutical Services March 25, 2002

    2. IPEC Excipient Master File: Outline IPEC background and strategy Format of the IPEC excipient master file guide Status of guide and future plans

    3. IPEC Excipient Master File Guide Documents used as reference ICH Common Technical Document PhEur Certificate of Suitability Procedure FDA Guideline for DMF’s IPEC Europe draft Guideline for Excipient Masterfiles FDA MAPP 5015.4 Chemistry Review for Drug Substance DMF’s Product Master File Guidelines for Canada

    4. Application of the EMF Guide Submission of information for a new excipient New route of administration Biopharmaceutical excipient Supply additional data when requested

    5. IPEC Excipient Master File Strategy DMF systems exist for excipients in the U.S. and Canada current file is unstructured No DMF system exists for excipients in Europe or Japan Initial IPEC-Americas Guideline focus on enhancing the current U.S. DMF system structure information to be used to fulfill ICH CTD P4 requirements

    6. IPEC Excipient Master File Strategy Concept being discussed with Europe and Japan Will allow for consistent submission of excipient information in all 3 regions to meet ICH CTD requirements and maintain confidentiality Accelerate overall review process Utilize DMF references by FDA when assessing generic applications for acceptance

    7. Types of Information Typically Needed List of Excipient Components (chemical/compendial names including viscosity and MW information) Quantitative percentages for each component Grade (USP/NF, PhEur, JP/JPE, CFR, FCC, EC Directive, etc.) Evidence of Prior use in Oral Applications at similar levels (especially US Generics, Japan)

    8. CTD - Section P4 Control of Excipients P4.1 Specifications (Q6B) P4.2 Analytical Procedures (Q2A, Q6B) P4.3 Validation of Analytical Procedures (Q2A, Q2B, Q6B) P4.4 Justification of Specifications (Q3C, Q6B) P4.5 Excipients of Human or Animal Origin (Q5A, Q5D, Q6B) P4.6 Novel Excipients (-)

    9. Excipient Master File The file is composed of two sections: Administrative Section (region specific based on submission specifics and local requirements) Core Technical Document (will include all technical details and summaries needed for excipient acceptance in most regions - including CTD P4 requirements)

    10. Excipient Master File

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