Quality Risk Management (QRM) is a fundamental component of pharmaceutical quality systems, playing a critical role in safeguarding patient safety, ensuring regulatory compliance, and supporting consistent product quality. Owing to the highly regulated nature of pharmaceutical manufacturing, systematic and science-based approaches are required to identify, assess, control, and review quality-related risks throughout the product lifecycle. This paper presents a comprehensive review of Quality Risk Management concepts, tools, and applications within the pharmaceutical industry. Emphasis is placed on widely adopted methodologies such as Failure Mode and Effects Analysis (FMEA), Quality by Design (QbD), and Process Analytical Technologies (PAT), and their roles across development, manufacturing, storage, and distribution stages. The reviewed literature is organized according to risk management phases and operational contexts to highlight current practices, benefits, and limitations. The findings indicate that effective implementation of QRM enhances decision-making, improves regulatory confidence, and promotes continuous improvement in pharmaceutical operations. This study provides a structured reference for practitioners and researchers seeking to strengthen risk-based quality management practices within pharmaceutical manufacturing environments.
Published in: 3rd GCC International Conference on Industrial Engineering and Operations Management, Tabuk, Saudi Arabia
Publisher: IEOM Society International
Date of Conference: February 2
-4
, 2026
ISBN: 979-8-3507-6175-7
ISSN/E-ISSN: 2169-8767