5 publications
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Published Subscription Review Article
Implementing Quality by Design (QbD): Strategies, Challenges, and Best Practices across IndustriesBy Patil Divyashree Kantilal, Mahale Devendra S, Amit Kumar R Dhankani, Mansi A Dhankani, Sunil P. Pawar
Abstract: The present comprehensive review investigated the dynamic landscape of quality standards within the pharmaceutical sector, with a primary focus on the implementation and impact of Quality by Design principles. It illuminated the multifaceted challenges encountered by pharmaceutical companies in upholding stringent quality standards amidst evolving regulatory requirements and complex manufacturing processes. By embracing Quality by Design principles, the industry aims to foster a proactive and systematic approach to product development …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 2, 2024 · pp. 28–36 Read article →
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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 Original Research
Navigating the Horizon: Current Trends in Elevating Quality Assurance in Clinical ResearchBy Patil Divyashree Kantilal, Patil Bhagyshri Sandip, Patil Bhushan Ravindra, Patil Divyani Rajendra
Abstract: The landscape of clinical research quality management has evolved significantly in recent years, driven by stringent regulatory frameworks and globalization of trials. This evolution underscores the importance of integrating quality into all aspects of the clinical trial process from design to postresearch activities. Concepts such as Good Clinical Practice (GCP) and Quality by Design (QbD) are central to ensuring the reliability and accuracy of trial data while safeguarding patient safety …
Published in Research & Reviews: A Journal of Drug Design & Discovery · Vol. 11, Issue 1, 2024 · pp. 1–8 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 →
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Published Subscription Review Article
Data Integrity Best Practices in Pharmaceutical Quality Assurance: A Thorough ReviewBy Patil Divyashree Kantilal, Amruta.N.Patil, Mansi Dhankani, Sunil.P.Pawar
Abstract: Data integrity stands as a linchpin in the reliability and trustworthiness of systems involved in handling, analyzing, and retrieving information, safeguarding the accuracy and consistency of data from inception to disposal. This paper delves into the multifaceted realm of data integrity, encompassing its definition, pivotal importance, regulatory underpinnings, core principles, and practical implementation strategies. A comprehensive exploration of regulatory guidelines, including ICH Q7, EU Annexure 11, and FDA regulations, underscores …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 22–30 Read article →