2 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 →