Optimal Applications of “In-Line” or “At-Line” Manufacturing Controls in Pharmaceutical Production

7/20/01


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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

Author: CDER USER