• Miss.Deepali Shivaji Chitale
• Dr.P.P.Udapurkar
• Prof.S.A.Lekurwale

Quality Management Systems (QMS) are vital components of contemporary pharmaceutical quality frameworks, offering a systematic and evidence-based method to guarantee product quality and ensure patient safety during the entire product lifecycle. Due to rising process complexity, worldwide supply chains, and strict regulatory demands, the pharmaceutical sector has transitioned from passive quality control to active risk-oriented quality assurance. The International Council for Harmonization (ICH) enhanced the formal recognition of QRM by publishing the ICH Q9, which establishes harmonized principles and tools for risk management applicable across development, manufacturing, and regulatory oversight. The ideas, legal framework, and methodical procedures of quality risk management in pharmaceuticals are all thoroughly covered in this review. Various qualitative and quantitative risk assessment tools, including Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), and risk ranking methodologies, are critically reviewed. The integration of QRM with Quality Design (QbD), Good Manufacturing (GMP), Validation, Change Management, and Pharmaceutical Quality Systems is stressed. Furthermore, actual applications of QRM in industrial operations, supply chain management, and regulatory decision-making are covered. The assessment also discusses issues connected with QRM implementation and future views, such as digitization and risk-based regulatory inspections. Overall, QRM is essential for attaining consistent product quality, regulatory compliance, and continual improvement in the pharmaceutical business. Index Terms: component, formatting, style, styling, insert.

Quality Risk Management, ICHQ9, Pharmaceutical Quality System, Risk Assessment Tools, GMP, Quality by Design

"A Comprehensive Review - Quality Risk Management (QRM) in Pharmaceuticals", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.13, Issue 1, page no.c389-c396, January-2026, Available :http://www.jetir.org/papers/JETIR2601246.pdf

"A Comprehensive Review - Quality Risk Management (QRM) in Pharmaceuticals", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.13, Issue 1, page no. ppc389-c396, January-2026, Available at : http://www.jetir.org/papers/JETIR2601246.pdf