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Published byBruce Booker Modified over 8 years ago
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Generic Industry’s Perspective on the New GMP Initiative 2002 Generic Pharmaceutical Association Kenneth Lavin, M.Sc. Director, Regulatory Compliance TEVA Pharmaceuticals USA
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Modernization and Consistent Enforcement of cGMPs is Needed: Center and Field District to District
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Best Approach: Guidance Documents Needed Examples: –Cleaning Validation –Process Validation –Training –Vendor Qualification
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Cleaning Validation Levels Matrix Approach Monitoring Program
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Process Validation Impact of Validation in Future Production Lessen requirements for commercial production. Unnecessary Testing.
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Training Level Documentation / Tracking
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Vendor Qualification Repeat of testing Reduced Testing Documentation / Rational
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Summary – Guidance GPhA welcomes the opportunity to work with FDA, industry and academia on developing the science to create the procedure to allow for a new regulatory framework.
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