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Ensuring Quality in Tablet Development: Compliance Challenges and Technological Solutions

This document emphasizes the critical importance of designing quality into the tablet manufacturing process, as articulated by industry experts in 1965. It explores various compliance issues and development challenges related to the manufacturing of pharmaceuticals, including environmental exposure, manufacturing technology, and the significance of raw materials such as APIs and excipients. The role of Analytical Process Technology (PAT) in enhancing efficiency and compliance is examined, alongside topics like dosage form uniformity and the impact of equipment choices on production outcomes.

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Ensuring Quality in Tablet Development: Compliance Challenges and Technological Solutions

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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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