Volume : 13, Issue : 07, July – 2026
Title:
APPLICATION OF QUALITY RISK MANAGEMENT IN PHARMACEUTICAL MANUFACTURING
Authors :
CH.Vijaya Durga, Mr. Sayed Shaffath Ali, Dr. Shaik Shabeer, Dr. P Poli Reddy
Abstract :
Quality Risk Management (QRM) is a systematic approach used in the pharmaceutical industry to identify, assess, control, communicate, and review risks associated with product quality throughout the product life cycle. The implementation of QRM has become increasingly important due to growing regulatory expectations and the need to ensure patient safety, product efficacy, and consistent manufacturing performance.
The present review-based thesis aims to evaluate the principles, methodologies, tools, applications, and regulatory perspectives of QRM in the pharmaceutical industry. This study is primarily based on an extensive review of published research articles, review papers, regulatory guidelines, and industry reports related to pharmaceutical risk management. Relevant literature was collected from scientific databases and official guidelines, with particular emphasis on the recommendations of International Council for Harmonisation.
The review highlights that QRM can be effectively integrated into various stages of the pharmaceutical product life cycle, including research and development, technology transfer, manufacturing, quality control, validation, packaging, storage, distribution, and post-marketing activities. Commonly used risk assessment tools such as Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), Risk Ranking and Filtering (RRF), and Preliminary Hazard Analysis (PHA) were evaluated for their applicability and effectiveness.
The findings indicate that the implementation of QRM enhances decision-making processes, improves product quality, facilitates regulatory compliance, minimizes potential failures, optimizes resource utilization, and strengthens patient safety. Overall, QRM serves as an essential component of modern pharmaceutical quality systems by promoting a proactive, science-based, and risk-focused approach to quality assurance.
Keywords: Quality Risk Management, Pharmaceutical Industry, ICH Q9, Risk Assessment, Patient Safety, Pharmaceutical Quality System, Risk Control
Cite This Article:
Please cite this article in press Sayed Shaffath Ali et al., Application Of Quality Risk Management In Pharmaceutical Manufacturing,, Indo Am. J. P. Sci, 2026; 13(07).
REFERENCES:
1.international conference on harmonisation of technical requriments for regestrtion of pharmaceuticals for human use; Quality risk management Q9 Current step 4 version dated 9 november 2005
2.TRS986 WHO good manufacturing practices for pharmaceutical product, annex 2 ;2014
3.Guidance for industry quality systems approach to pharmaceutical CGMP regulation, FDA; September 2006
4. Rawidh Alsaidalani and Bassam Elmadhoun; Quality Risk Management in Pharmaceutical Manufacturing, Operations: Case Study for Sterile Product Filling and Final Product Handling Stage, Journal sustainability, vol 14,4Aug 2022
5. Jain Sanjay kumar; Quality risk management -CAPA to prevent potential quality issues: Asian journal of pharmaceutical research and development; Jan- feb-2017, volume5
6.International conference on harmonisation of technical requirments for registration of pharmaceutical for human use; pharmaceutical quality system Q10; 4 version ;4june 2008
7. International conference on harmonisation of technical requirments for registration of pharmaceutical for human use; pharmaceutical development Q8[R2]; 4 version; august 2009
8. Guideline on the risk based approach according to aanex 1, part 4 directive 2001/83/EC appilied to advanced therapy medicinal plants; European medicinal agency ;11 February 2013
9.Gourav Kushwah, Dr. Gurmeet Chhabra*, Dr. Nimita Manocha, Gaurav Sarsodia; quality risk management; a current international pharmaceutical industry practices to optimize the product quality, international journal of pharmaceutical sciences, vol3,2025
10.Lotilkar mv; Quality risk management a review, journal of drug delivery &therapeutic;2013
11.Priya wagh, Ramdas Darade; quality risk management in pharmaceutical industry; A review; international journal of scientific research and technology, 2025
12. Marisuz zahbi; strategic assurance of quality risk management in pharmaceutical manufacturing industries, vol 8, issue 6;14-dec 2023
13.Abdul M. kaleem, Jebastin Kolipillai , Damodharan Narayanaswamy , mastering quality, uniting risk assessment with quality by design principles for pharmaceutical excellence; MHS-SRMIST; 08/30/2024
14. DR. Muhammad Nauman , Rehana Bano , implementation of quality risk management in pharmaceutical manufacturing industry; IOSR-JPBS, vol 9, issue1; jan 2014
15. Vivek P. Chavda1, Sandip Maru , & Bhargav Patel, How quality risk management is useful for pharmaceuticals, Global research journal of science and nature, vol 1; July – September- 2015
16. Sakshi s. gadekar, Sagar S.Sangale, Rutuja B. Phapale quality risk management; irjmets, vol 7; 11 november 2025
17.https://quality.eleapsoftware.com/glossary/quality-risk-management-trends-and innovations/ Retrivewed on 09/04/2026
18.https://www.pharmaguideline.com/2015/07/quality-risk-management-in-pharmaceuticals.html?m=1 Retrivewied on 10/4/2026
19. T. Frank , S.Brooks , R. Creekmore , B. Hasselbalch ,K. Murray , K.Obeng , S.Reich , E. Sanchez , quality risk management principles and industry case studies; December 28,2008
20.omar a. Ismael , I.AHMED, using quality risk management in pharmaceutical industries a study. October 2020; vol 21
21. joymalya bhattacharya; quality risk management-understanding and control the risk in pharmaceutical manufacturing industry. International journal of pharmaceutical science invention, January 2015; volume 4[issue]
22. Amrita Das1, Praveen Kadwey1, Jai Kumar Mishra2, *Sudheer Moorkoth, quality risk management in pharmaceutical industry; tools and methodology. International journal of pharmaceutical quality assurance:2014
23. Elena Stocker , Karin Becker , Siddhi Hate , Roland Hohl , Wolfgang Schiemenz, Stephan Sacher , Andreas Zimmer , Sharareh salar -behazadi ;application of ICH Q9 quality risk management tools for advanced development of hot melt coated multiparticulate systems; journal of pharmaceutical sciences ;2016
24.Norikata Hashii, Akiko Ishii-Watabe Akihiko Hirose , Noriko Katori , Norikata Hashii , Susumu Arai , Hirotoshi Awatsu , Akira Eiza , Yoshiaki Hara , Hideshi Hattori, Tomomi Inoue , Tetsuya Isono, Masahiro Iwakura, Daisuke Kajihara, Nobuo Kasahara, Hiroyuki Matsuda, Sei Murakami, Taishiro Nakagawa, Takehiro Okumura, Takeshi Omasa , ShinyaTakuma, Iyo Terashima , Masayoshi Tsukahara , Maiko Tsutsu , Takahiro Yano , Nana Kawasaki; approaches to quality risk management when using single-use systems in the manufacture of biologics. AAPS pharma sci tech; October 2015.vol 5
25.H. Gregg claycamp, perspective on quality risk management of pharmaceutical quality drug information journal; vol.41,2017
26.R.P. VARATAK, G.R. BHAGURE, quality risk management in pharmaceutical industry; a overview; Asian journal of chemistry,2015, vol 24 ,5576-5578
27. V Vijayakumar Reddy*, N Vishal Gupta, H V Raghunandan, U Nitin Kashyap, Quality risk management in pharmaceutical industry; A Review
28. Gite Jayshri Ramhari, Bidave Sakshi Dagadu, Murkute Vishal Sampat, Thorve Kamalesh Dattatray, Dr.Datkhile; Risk assessment and management tools in quality assurance, international journal of advanced research in science, communication and technology, vol 4, December 2024
29.Rawidh Alsaidalani and Bassam Elmadhoun; Risk management in pharmaceutical supply chain, warehousing and dispensing practical case study from sterile pharmaceutical industry, international journal of pharmaceuticals sciences review and research, may-june 2021