Table of Contents
Optimal Applications of “In-Line” or “At-Line” Manufacturing Controls in Pharmaceutical Production
ACPS Meeting Discussion: Objectives
Process Analytical Chemistry
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Impact on Product Quality
Product Development: Evolution
Product Development Process
Product Development Knowledge
Controlling Unit Operations
Limitations of current approach
Current Situation: In-Process Tests
Process Validation: Limitations?
PROCESS D WITH QC TESTS: Cycle Times including BULK ACTIVE
Process Controls: Evolution.......
Modern In-Process Controls
Example: Direct compression tablet formulation
Inhomogeneity in Experimental Product Hand Blended Preparation (FDA)
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Distribution of Lubricant in Blend
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Challenges
Summary
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