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

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;