Process Validation of Paracetamol Tablets: A Comprehensive Study Based on ICH Guidelines

Authors

  • Ritika Bhatia Research Scholar, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur
  • Mo. Firoj Tanwar Research Scholar, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur
  • Rakesh Goyal Professor, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur
  • Dilip Agarwal Principal, Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur

DOI:

https://doi.org/10.32553/ijmbs.v7i6.2712

Abstract

This research paper aims to provide a comprehensive understanding of the process validation of Paracetamol tablets according to the guidelines outlined by the International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use (ICH). Paracetamol is a widely used analgesic and antipyretic drug, and ensuring the quality, safety, and efficacy of its dosage form is of utmost importance. This study encompasses the three stages of process validation, namely process design, process qualification, and continued process verification, with a focus oncritical parameters and attributes. The article also explores the role of regulatory guidelines, such as the ICH Q8 (R2), Q9,and Q10, in facilitating effective process validation. (1)

Key words: Process Validation, ICH, CPP, CQA, SPC, Change Control, VMP;

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Published

2023-06-12

How to Cite

Bhatia, R. ., Tanwar, M. F. ., Goyal, R. ., & Agarwal, D. . (2023). Process Validation of Paracetamol Tablets: A Comprehensive Study Based on ICH Guidelines. International Journal of Medical and Biomedical Studies, 7(6), 01-10. https://doi.org/10.32553/ijmbs.v7i6.2712

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Section

Articles