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Development/Compliance Issues (Tablets)

Development/Compliance Issues (Tablets). “It is important to design quality into the process” 1965 - PMA spokesperson and T. Byers, FDA. Hank Avallone Executive Director, Regulatory Compliance Pharmaceutical Sourcing Group Americas. Development/Compliance Issues.

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Development/Compliance Issues (Tablets)

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  1. Development/Compliance Issues (Tablets) “It is important to design quality into the process” 1965 - PMA spokesperson and T. Byers, FDA Hank Avallone Executive Director, Regulatory Compliance Pharmaceutical Sourcing Group Americas

  2. Development/Compliance Issues • Environmental/Operator Exposure • Manufacturing Technology • Raw Materials - APIs/Excipients • Equipment - Closed/Cleanable • Operating Costs • Minimal Steps • Cycle Time

  3. Development/Compliance Issues • Improvements using Analytical Technology (PAT) • Exposure of Flaws • Compliance • Nonconformances/Documentation Review • Dose Uniformity • Dissolution • Impurities

  4. Active Pharmaceutical Ingredient (API) • Physical Form API • Prior to Milling - Major Validation Criteria [variability in the crystallization / manufacturing process can result in variability in the physical form and/or impurities of the API] • Dosage Form Formulation/API Developer Communication

  5. Excipients • Minimum number in formulation • Excipient Blend Uniformity (dissolution variability) • Physical Form • tight specifications • multiple source / one grade

  6. Equipment • Screen, Blend, Compress • Cleanable / Closed Systems • Bin vs. Fluid Bed • WIP Tablet Press

  7. PAT • Identification of flaws in the process if the process is not properly developed

  8. Compliance • Direct Compression Process • less steps, less variables, less opportunities for nonconformances • more complex process, more controls, more software, more information, longer review, longer cycle time, more WIP/Rejections

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