Paper Contents
Abstract
The pharmaceutical industry operates in a highly regulated environment, where analytical method and process validation play pivotal roles in ensuring product quality and safety. To facilitate global harmonization and streamline regulatory requirements, international organizations like the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Association of Southeast Asian Nations (ASEAN) have developed guidelines for these critical aspects. This comparative study aims to comprehensively analyze the similarities and differences between the ICH and ASEAN guidelines pertaining to analytical method and process validation. By examining key elements such as scope, principles, requirements, and acceptance criteria, the study seeks to provide a clear understanding of the harmonized and divergent aspects of these guidelines. The comparison will cover a wide range of topics, including:Analytical method validation: This includes aspects such as specificity, linearity, accuracy, precision, range, detection limit, and quantification limit.Process validation: This encompasses topics like design of experiments, process performance qualification, and continued process verification.Ultimately, this study will contribute to a better understanding of the regulatory landscape for pharmaceutical manufacturing and quality control. By highlighting the commonalities and differences between the ICH and ASEAN guidelines, it will provide valuable insights for pharmaceutical companies, regulatory authorities, and industry stakeholders seeking to ensure compliance with international standards and best practices.Key Words: Regulatory affairs, Regulatory Agencies, FDA, ICH and ASEAN guidelines
Copyright
Copyright © 2024 B. DineshKumar. This is an open access article distributed under the Creative Commons Attribution License.
