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Stage 1A Process Design: Quality by Design

  • Ajay Babu Pazhayattil
  • Naheed Sayeed-Desta
  • Emilija Fredro-Kumbaradzi
  • Jordan Collins
Chapter
Part of the AAPS Introductions in the Pharmaceutical Sciences book series (AAPSINSTR)

Abstract

Quality by design (QbD) (US FDA, Quality by design for ANDAs: an example for immediate-release dosage forms, 2012) approach in product development has become a norm as Regulatory Agencies are basing their decisions on submitted product on the review of the scientific information generated and presented in a systematic way. It reduces the issues and burden at process validation stage and throughout the commercial manufacture. Consequently, it reduces the need for post approval changes driven by processing issues but also facilitates approval of process improvement changes that may fall within the originally studied design space.

Keywords

Quality by design Process design Quality target product profile Critical quality Attributes Critical process parameter Control strategy Design space 

References

  1. 1.
    Maguire J, Peng D. How to identify critical quality attributes and critical process parameters, Office of Process and Facility (OPF) OPQ/CDER/FDA, FDA/PQRI 2nd conference, North Bethesda, MD. 2015.Google Scholar
  2. 2.
    Torbeck LD. Pharmaceutical and medical device validation by experimental design. Boca Raton: CRC Press; 2007.CrossRefGoogle Scholar
  3. 3.
    Cavazzuti M. Optimization methods: from theory to design. Berlin, Heidelberg: Springer-Verlag; 2013.CrossRefGoogle Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Ajay Babu Pazhayattil
    • 1
  • Naheed Sayeed-Desta
    • 2
  • Emilija Fredro-Kumbaradzi
    • 2
  • Jordan Collins
    • 3
  1. 1.Eurofins Alphora Reserach Inc. (Canada)TorontoCanada
  2. 2.Apotex (Canada)TorontoCanada
  3. 3.IQVIA (Canada)TorontoCanada

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