Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines

Abstract

Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature.

Summary: In the pharmaceutical industry, ensuring the quality, safety, and effectiveness of medicinal products is of utmost importance. Analytical Method Validation (AMV) and Process Validation (PV) are critical procedures in pharmaceutical manufacturing, vital for upholding product quality and adhering to regulatory standards. This thesis undertakes a comparative examination of AMV and PV guidelines from prominent regulatory authorities, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the World Health Organization (WHO), and the Association of Southeast Asian Nations (ASEAN).

The study delves into the foundational principles, methodologies, and regulatory requirements outlined by each guideline to assess their alignment and differences. It scrutinizes key aspects such as validation parameters, acceptance criteria, documentation requirements, and statistical approaches to identify commonalities and disparities among the guidelines. Furthermore, this research aims to offer insights into the practical implications of adhering to multiple regulatory frameworks concurrently. It examines the challenges pharmaceutical companies encounter in navigating divergent requirements and harmonizing validation processes across various regions. Additionally, potential strategies to streamline compliance efforts and optimize resource allocation are explored.

By synthesizing the findings of this comparative analysis, stakeholders in the pharmaceutical industry can gain a comprehensive understanding of the regulatory landscape governing AMV and PV practices. Moreover, the insights derived from this study can inform the development of harmonized validation protocols that facilitate global market access while maintaining the highest standards of product quality and patient safety.

Conclusion: Notable variations exist in validation approaches, but all emphasize product quality, safety, and efficacy. Pharmaceutical companies must navigate diverse regulatory landscapes for compliance.