Comparative Analysis of Analytical Method Validation Requirements Across ICH, USP, ChP and ANVISA: A Review

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dc.contributor.authorElumalai, Sen_US
dc.contributor.authorDantinapalli, VLSen_US
dc.contributor.authorPalanisamy, M.en_US
dc.date.accessioned2025-05-12T10:23:18Z
dc.date.available2025-05-12T10:23:18Z
dc.date.issued2024-12
dc.description.abstractThis comprehensive guide provides a detailed comparison of analytical method validation requirements across four major regulatory bodies: the International Council for Harmonisation (ICH), United States Pharmacopeia (USP), Chinese Pharmacopoeia (ChP), and Brazilian Health Regulatory Agency (ANVISA). The study examines key aspects of method validation, including scope, validation parameters, acceptance criteria, and regulatory compliance. These guidelines have been chosen due to major differences between regulations requirements and ICH guidelines, leading to a huge challenge for the Health Authority and the locally established Pharmaceutical Companies to implement these guidelines. Implementing the revised or upcoming ICH guidelines will benefit the industry and health authorities. Recent revisions by the guidelines will help to align with other chosen regulatory authorities to reduce duplicate work and contribute to the global regulatory harmonization, which will bring a great benefit to the regulatory bodies review process, industrialist approval and important medicines approval will be faster available to the patients.en_US
dc.identifier.affiliationsAmbio Pharm, Inc.,1024 Dittman Court, North Augusta, SC 29842, USAen_US
dc.identifier.affiliationsVeranova, 58 Spencer Rd Boxborough MA, 01719, USAen_US
dc.identifier.affiliationsHikma Pharmaceuticals, Columbus, OH, 43228, USA.en_US
dc.identifier.citationElumalai S, Dantinapalli VLS, Palanisamy M.. Comparative Analysis of Analytical Method Validation Requirements Across ICH, USP, ChP and ANVISA: A Review . Journal of Pharmaceutical Research International. 2024 Dec; 36(12): 54-71en_US
dc.identifier.issn2456-9119
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/247690
dc.languageenen_US
dc.publisherMs. M. B. Mondalen_US
dc.relation.issuenumber12en_US
dc.relation.volume36en_US
dc.source.urihttps://doi.org/10.9734/jpri/2024/v36i127628en_US
dc.subjectICH guidelinesen_US
dc.subjectUnited States of Pharmacopoeia (USP)en_US
dc.subjectChinese Pharmacopoeia (ChP)en_US
dc.subjectBrazil/ANIVISA guidelinesen_US
dc.subjectWorld Health Organization (WHO)en_US
dc.subjectanalytical method validationen_US
dc.titleComparative Analysis of Analytical Method Validation Requirements Across ICH, USP, ChP and ANVISA: A Reviewen_US
dc.typeJournal Articleen_US
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