2 publications
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Published Subscription Review Article
Navigating Risk-Based Approaches in Quality Assurance: Strategies, Implementation, and ImpactBy Patil Divyashree Kantilal, Divyani Rajender Patil, Mahale Devendra S, Amit Kumar R Dhankani, Mansi A Dhankani, S.P. Pawar
Abstract: This review investigates the implementation of a risk-based approach within Quality Management Systems (QMS) as stipulated by ISO 9001:2015 regulations. It scrutinizes the challenges organizations encounter when transitioning to ISO 9001-2015 requirements, particularly focusing on the alignment of conceptual frameworks and processes among stakeholders. A key objective of this review is to propose a refined definition of "quality risk" and "risk-based thinking in QMS" to address the idiosyncratic characteristics of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 2, 2024 Read article →
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Published Subscription Review Article
Advancements in Method Development and Validation for Levocetirizine: A Comprehensive ReviewBy Patil Divyashree Kantilal, Amit Kumar R Dhankani, Mansi A Dhankani, S.P. Pawar
Abstract: This review article delves into the intricate realm of concurrent estimation of multiple compounds, with a specific emphasis on Levocetirizine and its related substances. It looks into how to improve analytical process specificity by using reverse phase high-performance liquid chromatography (RP-HPLC) in conjunction with UV detection. The study meticulously explores the intricacies of method development and validation, offering invaluable insights into the realms of precision and accuracy within pharmaceutical analysis. …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 15–27 Read article →