Process Validation of Paracetamol tablet as per ICH guidelines

Abstract

Process validation is an integral part of pharmaceutical manufacturing, ensuring that tablets are consistently produced with quality and efficacy in line with regulatory requirements. The International Council for Harmonization ICH) provides guidelines for the systematic validation of manufacturing processes. This research article presents a comprehensive study on process validation for Paracetamol tablets following the ICH guidelines. The article focuses on various aspects of the validation process, including process design, qualification, and continued process verification, with specific emphasis on Paracetamol tablet manufacturing. Experimental studies were conducted to characterize the critical process parameters and assess their impact on the tablet's quality attributes. The article also discusses the use of statistical analysis techniques for data evaluation and demonstrates the establishment of a robust validation protocol for Paracetamol tablet manufacturing. Through the application of the ICH guidelines, this research contributes to ensuring the consistency and reliability of Paracetamol tablets, enhancing patient safety and meeting regulatory expectations.

Keywords: Process validation, ICH guidelines, Critical process parameters, Critical Process Attribution, Statistical analysis, and validation protocol;