Stage 2A and Stage 2B: Process Qualification

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


The process qualification stage verifies that the commercial process developed is capable of reproducible commercial manufacturing. Stage 2 is required prior to product commercialization and establishes the process with scientific evidence that it is capable of consistently delivering quality drug products. Qualification activities for facility, equipment, and utilities (Stage 2A) are conducted prior to use in commercial Stage 2B activities.


Process qualification Stage 2A Stage 2B Commercial distribution Statistical assessment acceptance criteria FDA 


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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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