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Excipients

Excipients
(Chair) Robert Wiens

Excipients
(Chair) Robert Wiens

The Excipients WG is developing current practices for control of excipients and will explore ways for more efficient controls.

Joint Position Paper from Excipient Manufacturers, Drug Product Manufacturers and USP on Pharmaceutical Excipient Testing and Control Strategies; Based on a PQRI Survey and Workshop

PQRI Survey Findings of Pharmaceutical Excipient Testing and Control Strategies, Used By Excipient Manufacturers, Excipient Distributors and Drug Product Manufacturers

Draft Guidance for Industry on Drug Product: Chemistry, Manufacturing, and Controls Information (2003)http://www.fda.gov/cder/guidance/1215dft.pdf

Joint Position Paper From Excipient Manufacturers, Drug Product Manufacturers and USP on Pharmaceutical Excipient Testing and Control Strategies; Based on a PQRI Survey and Workshop (PDF)

Work Plan

  • Excipient Control Strategy Work Plan (PDF)
    • Survey Timeline

Meeting Minutes

  • April 7, 2005 (PDF)
  • March 24, 2005 (PDF)
  • March 17, 2005 (PDF)
  • March 3, 2005 (PDF)
  • January 27, 2005 (PDF)
  • January 13, 2005 (PDF)

PQRI Structure

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