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    The control strategy for a pharmaceutical product is comprised of a comprehensive collection of raw material, equipment and process controls, analytical limits, and a change management program.  At the root of each of these is a scientifically meaningful definition of product quality.  This is ideally based on compendial, safety and efficacy considerations.  More typically limits are based on manufacturing history.  This presents several complications related to implementation of Quality by Design, assurance of process robustness, and maintenance of product supply.  Early limits are based on a limited number of manufactured lots and lack of experience with the lifecycle of manufacturing.  This talk will describe a vision for a control strategy built upon a foundation of scientifically meaningful quality, and with appropriate control of manufacturing variability and change management.

  • : Timothy Schofield
  • : Independent Consultant
  • : Timothy Schofield
  • : quality
  • : intermediate
  • : timothylschofield@gmail.com
  • : 610-608-7649
The Need for a Scientifically Meaningful Definition of Quality in Pharmaceuticals