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Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving Regulatory Environment



WEBINAR

Abstract

This webinar will discuss appropriate quality attributes for different raw material uses, present strategies to support identification, selection and risk assessment of raw materials, and highlight the importance of regulatory documentation.
Recent and continuing regulatory improvements require drug manufacturers to assess and mitigate risk throughout their entire processes. This includes raw materials used at every stage of manufacturing and clinical phases. Current regulatory guidelines and industry standards clearly define quality requirements for raw materials that are incorporated into, or used close to, final drug product, for example active ingredients and excipients. However, no such clear standards are defined for chemicals used earlier in the process, such as in upstream bioprocessing, early chemical synthesis stages, or clean-in-place. The absence of such standards presents a challenge to efficiently and effectively source raw materials with appropriate supply chain transparency and control, accompanied by the necessary supporting documentation

In this webinar, you will learn:

  • Strategies to support identification, selection, and risk assessment of raw materials throughout the manufacturing process
  • Appropriate quality attributes for different raw material uses
  • The importance of quality and regulatory documentation provided by the supplier

Speaker

Douglas Bowman

Douglas Bowman

MilliporeSigma

Emprove® Program Manager