Skip to main content
SpringerLink
Log in

Life Cycle Approach to Process Validation

  • Chapter
  • First Online:
Solid Oral Dose Process Validation

Part of the book series: AAPS Introductions in the Pharmaceutical Sciences ((AAPSINSTR))

  • 701 Accesses

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.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  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.pdf

    Google Scholar 

  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. European Commission (EC). Guidelines on good manufacturing practice for medicinal products, Annex 15. 2014.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Eurofins Alphora Reserach Inc. (Canada), Toronto, ON, Canada

    Ajay Babu Pazhayattil

  2. Apotex (Canada), Toronto, ON, Canada

    Naheed Sayeed-Desta & Emilija Fredro-Kumbaradzi

  3. IQVIA (Canada), Toronto, ON, Canada

    Jordan Collins

Authors
  1. Ajay Babu Pazhayattil
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Naheed Sayeed-Desta
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Emilija Fredro-Kumbaradzi
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Jordan Collins
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

Copyright information

© 2018 American Association of Pharmaceutical Scientists

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Pazhayattil, A.B., Sayeed-Desta, N., Fredro-Kumbaradzi, E., Collins, J. (2018). Life Cycle Approach to Process Validation. In: Solid Oral Dose Process Validation. AAPS Introductions in the Pharmaceutical Sciences. Springer, Cham. https://doi.org/10.1007/978-3-030-02472-7_1

Download citation

Publish with us

Policies and ethics

Search

Navigation