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Generic Industry’s Perspective on the New GMP Initiative

Generic Industry’s Perspective on the New GMP Initiative. May 21, 2003 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance TEVA Pharmaceuticals USA. Risk-Based Approach . Definition Implementation Benefits Dialogue Guidance.

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Generic Industry’s Perspective on the New GMP Initiative

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  1. Generic Industry’s Perspective on the New GMP Initiative May 21, 2003 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory ComplianceTEVA Pharmaceuticals USA

  2. Risk-Based Approach • Definition • Implementation • Benefits • Dialogue • Guidance

  3. Changes to Approved Applications • Interim Specifications • Development Report: • Guidelines • How to be used • No Negative Impact on Review • Goals

  4. Pre-Approval Inspections • No longer universally necessary • Except Novel Compounds & New Technologies • Chemistry Reviewer Inspections • No Delays

  5. Communications • 483 Dispute Resolution • Publish Internal FDA polices and Procedures • Publish Control Documents • Proceduralize Pre-ANDA meetings

  6. Summary – Guidance & Procedures • GPhA welcomes the opportunity to work with FDA, industry and academia on developing the science to create the procedures to allow for a new regulatory framework.

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