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Innovation and Continuous Improvement in Pharmaceutical Manufacturing

By Ajaz Hussain (Chairperson) Raafat Fahmy (CVM); William Bargo (CVM); Robert Coleman; Robert (ORA); Elise Murphy (ORA); Frank Holcombe Jr (CDER); Chris Watts (CDER); See Lam (CDER); Jon Clark (CDER); Christopher Joneckis (CBER); John Dietrick (CDER); Diana Kolaitis (ORA); Vilayat Sayeed (CDER); Mai Huynh (CVM); Norman Schmuff (CDER); Andrew Chang (CBER)

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Category

Document

Published on CMKC

Abstract

The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century

Type of publication

White Paper

Affiliations

  • FDA

Classification Areas

  • PAT
  • Regulatory

Tags

  1. FDA
  2. ICH
  3. pat
  4. Process analytical technology
  5. regulatory