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Life Cycle Approach to Process Validation

  • 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

Process validation activities align with the product lifecycle concept of ICH Q8, Q9, and Q10 (ICH, International Conference on Harmonisation of technical requirements for the registration of pharmaceuticals for human use (ICH) guidance document: Q8 (R2): pharmaceutical development, Geneva, 2009; ICH, International Conference on Harmonisation of technical requirements for the registration of pharmaceuticals for human use (ICH) guidance document: Q9: quality risk management, Geneva, 2005; ICH, International Conference on Harmonisation of technical requirements for the registration of pharmaceuticals for human use (ICH) guidance: Q10: pharmaceutical quality system, Geneva, 2008) that link product and process development, qualification of commercial manufacturing and maintenance of the process in a state of control during routine production. The regulators and industry have been adopting process validation lifecycle concepts.

Keywords

Process validation Life cycle Process design Process performance qualification Continued process verification 

References

  1. 1.
    US FDA. Guidance for industry, process validation: general principles and practices. White Oak: US Food and Drug Administration; 2011. www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdfGoogle Scholar
  2. 2.
    Alsmeyer D, Pazhayattil A. A case for stage 3 continued process verification. Pharma Manuf J. 2014.; http://www.pharmamanufacturing.com/articles/2014/stage3-continued-process-verification
  3. 3.
    European Commission (EC). Guidelines on good manufacturing practice for medicinal products, Annex 15. 2014.Google 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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