Comparison of Analytical Method validation guidelines used for release, stability in Biosimilar Manufacturing process.

Authors

  • Narra Naga Pavan Kumar Department of Biotechnology, Vignan’s Foundation for Science, Technology and Research, Vadlamudi, 522213, Guntur, Andhra Pradesh, India
  • Ajay Pakalapati Department of Biotechnology, Vignan’s Foundation for Science, Technology and Research, Vadlamudi, 522213, Guntur, Andhra Pradesh, India
  • K. Chandrasekhar Department of Biotechnology, Vignan’s Foundation for Science, Technology and Research, Vadlamudi, 522213, Guntur, Andhra Pradesh, India
  • Chandrasai Potla Durthi Department of Biotechnology, National Institute of Technology Warangal, Warangal, Telangana, India

DOI:

https://doi.org/10.5530/ctbp.2024.2.28

Keywords:

Food and Drug Administration, European Medicines Agency, ICH, critical quality attribute, Method Validation, QTPP

Abstract

Analytical method validation is the process of verifying a method for its purpose of fit, whether it suffices its intended application or not. Analytical method validation is a mandatory requirement to be fulfilled for measuring critical quality attributes (CQA) during the manufacturing process to get a drug approval for human, and veterinary use. As the drug approval process differs from one country to another in a similar way method validation guidelines also differ from one country to another, these requirements will be added as your country of approval differs, In the present review an attempt was made to bring all method validation guidelines in a comparative manner by comparing country-specific requirements these countries/organizations hold the major pharma market and the Stringent regularity countries. The paper majorly focuses on the analytical method used in the Biosimilar manufacturing process and its validation approach by comparing the method validation guidelines from the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH), USA, European Medicines Agency (EMA), Japan and India with the CQAs monitored during the biosimilar manufacturing process.

Results are Precise but not accurate

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Published

24-04-2024

How to Cite

Pavan Kumar, N. N. ., Pakalapati, A. ., K. Chandrasekhar, & Potla Durthi, C. . (2024). Comparison of Analytical Method validation guidelines used for release, stability in Biosimilar Manufacturing process. Current Trends in Biotechnology and Pharmacy, 18(2), 1798–1812. https://doi.org/10.5530/ctbp.2024.2.28