Advancing Quality Risk Management: A Comparative Overview of Traditional and Modern Tools in Pharma

Authors

  • Sayan Samanta
  • Pratyush Kumar Brahma
  • Sanjesh Rathi

Keywords:

Quality Risk Management, Process Analytical Technology, Artificial intelligence, Regulatory Compliance, Pharmaceutical Manufacturing

Abstract

A key component of pharmaceutical manufacturing, quality risk management (QRM) guarantees patient safety, product quality, and regulatory compliance throughout the product lifecycle. ICH Q9 and its Q9(R1) version refined risk assessment formality, decision-making, and product availability concerns. The conventional tool includes hazard analysis, FMEA, HACCP, and fault-tree analysis; innovative uses of real-time release testing, statistical process control, and risk-based oversight showed added value. Real-time monitoring and adaptable, flexible decision-making to reduce errors are made possible by technologies like PAT and continuous manufacturing. Although there are still challenges with understanding and governance, the potential given by digitalization, AI, ML, and predictive analytics enhance early deviation discovery and probabilistic evaluation. Newer technologies like digital twins and blockchain offer scenario testing, supply-chain resiliency, and traceability.Although there are still challenges with understanding and governance, the potential given by digitalization, AI, ML, and predictive analytics enhance early deviation discovery and probabilistic evaluation. Newer technologies like digital twins and blockchain offer scenario testing, supply-chain resiliency, and traceability.Still the limitations in ML understanding , regulatory harmonization, scalable digital twin adoption, and cross-industry benchmarking persists. The present status, developments, and prospects of QRM across global pharmaceutical production are highlighted in this article

Downloads

Download data is not yet available.

References

Jain Sanjay Kumar. Quality Risk Management–Application review in pharmaceutical and Biopharamceutical industries by Lorely MILCA Caceres. Bioprocessing Journal. 2010: 26-37

2. Sravya Sivadasu, Gangadharappa H.V, Kiran H.C, Annjewel Jose. Guidance for industry Q9 Quality Risk Management by US department of Health and Human Services, Food and drug Administration. Center for Drug and Evaluation Research. 2006.

3. Sravya Sivadasu, Gangadharappa H.V, Kiran H.C, Annjewel Jose. WHO Guideline on Quality Risk Management A draft guidance. 2010.

4. Imran Bakshi, Kartika Puri, Sukhbir Kaur. International Conference on Harmonization Guidance for Industry: Q9 Quality Risk Management. ICH; 2006

5. Ana Sim˜oes, Francisco Veiga, Carla Vitorino Question-based review for pharmaceutical development: An enhanced quality approach. European Journal of Pharmaceutics and Biopharmaceutics.

6. Nirmal Kumar, Ajeya Jha. Quality risk management during pharmaceutical ‘good distribution practices’–A plausible solution, Bulletin of Faculty of Pharmacy, Cairo University.

7. Sanjay Kumar Jain, Jitendra Kumar Jain, Jagdish Gohel and BhavikSanghavi. Quality risk assessment of equipment with PLC/HMI/SCADA in pharmaceutical industry. The Pharma Innovation Journal. 2022; 11(4): 616-622

8. Abhishek Maithani, Kumar Gaurav. Quality Risk Management (Q9): An Overview. International Journal of Pharmaceutical and Medicinal Research Int. J. Pharm. Med. Res. 2014; 2:68-71

9. Sumukha Krishna P, Gangadharappa HV, Nagendra S, Hemanth Kumar S. An Overview of Risk Management and Risk-based Cleaning Validation. International Journal of Research in Pharmaceutical Sciences. 2020;11(4):5407-5414

10. Aachchhadita Sharma, Raju Mari Jeyaprakash, Rinchi Bora, Abinash Chandra. Review article: Impact of Quality Risk Management Process in Pharmaceutical Industry to Curtail the Non-Conformity.

11. T. A. Mandhare, P.R. Khuspe, P. S. Nangare, R. D. Vyavhare Quality Risk Management: A Review American Journal of Pharm Tech Research. 2018; 8(2).

12. Aachchhadita Sharma, Raju Mari Jeyaprakash, Rinchi Bora, Abinash Chandra. Critical Review of Risk Assessment Tools in Pharmaceutical Quality by Design. Indian Journal of Pharmaceutical Education and Research, 2024; 58(4).

13. Madhavi E. Kadam, Dhwani Bhavsar. A Review of Total Quality Management In Pharmaceutical Industries. International Journal of Creative Research Thoughts (IJCRT). 2022; 10(3).

14. Amrita Das, Praveen Kadwey, Jai Kumar Mishra, Sudheer Moorkoth. Quality Risk Management (QRM) in Pharmaceutical Industry: Tools and Methodology, International Journal of Pharmaceutical Quality Assurance. 2014; 5(3); 13-21.

15. Zanje Abhijit L., Jadhav Vaibhav A. A Review of Total Quality Management in Pharmaceuticals. International Journal of Research Publication and Reviews. 2022; 3(6): 2401-2409

16. Shridhar Betkar, Trupti Nikwade. Review on Quality Assurance and Risk Management in Pharmaceuticals. International Journal of Research Publication and Reviews. 2023; 4(5); 5659-5666.

17. Lotlikar MV. Quality Risk Management (QRM): A Review, Journal of Drug Delivery & Therapeutics. 2013; 3(2): 149-154

18. V. Aswini and K. Kathiresan. Quality Risk Management (QRM): A Review. International Journal of Biology, Pharmacy and Allied Pharmacy. 2022; 11(10): 4667-4678

19. Thomas A. Little, Quality Risk Management for Drug Products and Drug Substances, BioProcess International. 2014; 12(5).

20. Bhawna Sharma. Role of Effective Quality Risk Management in Drug Safety Project, Harrisburg University of Science and Technology Digital Commons at Harrisburg University.

21. Omar A. Ismael, Moyassar I. Ahmed. Using Quality Risk Management in Pharmaceutical Industries: A Case Study. 2020.

22. V Vijayakumar Reddy, N Vishal Gupta, H V Raghunandan, U Nitin Kashyap. Quality Risk Management in Pharmaceutical Industry: A Review. /International. Journal. Pharm Tech Res. 2014; 6(3): 908-914.

23. Ranjana Suryawanshi, Aparark Mohalkar, Radhabai Jadhav, Manjusha Bhange, Ashwini Jankar. Implementation of Quality Risk Management (QRM) In Pharmaceutical Industry: A Review. World Journal of Pharmaceutical Research. 2015; 4(11).

24. Guidance for industry “Q9 Quality Risk Management” by US department of Health and Human Services, Food and drug Administration, Center for Drug and Evaluation Research, June 2006.

25. WHO Guideline on Quality Risk Management A draft guidance August 2010.

26. 3.Implementation of ICH Q9 in the Pharmaceutical Field an Example of Methodology from PIC/S 2010

27. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Q9 Quality Risk Management. Geneva: ICH; 2005.

28. International Conference on Harmonization Guidance for industry: Q9 Quality Risk Management. ICH; 2006.

29. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Q9 Quality Risk Management. Geneva: ICH; 2005.

30. Vjayakumar R, Vishal G, Raghunandan V, Nitin KU. Quality risk Management in Pharmaceutical Industry: A Review. Int J Pharm Tech Res. 2014; 6: 908-14.

31. ISO; 2000. Application of Risk Management to Medical Devices, ISO 14971; 2000. Available from: http://www.iso.org. [Last accessed on 2018 Dec].

32. Das, A. Quality Risk Management (QRM) in Pharmaceutical Industry: Tools and Methodology. International Journal of Pharmaceutical Quality Assurance. 2014; 5: 13–21.

33. Edward 2005. Risk-Based Cleaning Validation in Biopharmaceutical API Manufacturing. Biopharminternational.com.

34. FDA. Guidance for industry-quality systems approach to pharmaceutical cGMP regulations. Risk Manag. 2006:1-28.

35. Wallace CA, Holyoak L, Powell SC, Dykes FC, HACCP. The difficulty with Hazard Analysis. Food Control. 2014; 35(1): 233-40.

36. WHO. Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals. World Health Organ Tech Rep S. 2003; 908: 99-112.

37. FDA. Guidance for industry-quality systems approach to pharmaceutical cGMP regulations. Risk Manag. 2006:1-28

38. European Medicines Agency (EMA). ICH Guideline Q9 on quality Risk Management. 2014; 44(1):1-20.

39. Risk Assessment Guidance. Health and safety services. University of Leeds:1-37 Quality and Risk Management Standard. Feidhmeannachtnaseirbhi Slainte. Health Service Executive. 2007: 1-23.

40. Duarte JG, Duarte MG, Piedade AP, et al. Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance. AAPS J. 2025;27(96). doi:10.1208/s12248-025-01079-w.

41. Gómez JC. Operational Risk Management in the Pharmaceutical Industry: A Methodological Approach Using Ontologies and Fuzzy Quality Function Deployment. Procedia CIRP. 2020;90:47–52. doi:10.1016/j.procir.2020.01.010.

42. Claycamp HG. Perspective on Quality Risk Management of Pharmaceutical Quality. Drug Inf J. 2007;41(4):353–367. doi:10.1177/009286150704100309.

43. Haleem RM. Quality in the Pharmaceutical Industry – A Literature Review. Int J Pharm Sci Rev Res. 2015;34(2):1–8.

44. Arden NS, Haugum K, Haugum T, et al. Industry 4.0 for Pharmaceutical Manufacturing: Preparing for the Future. Int J Pharm. 2021;599:120464. doi:10.1016/j.ijpharm.2021.120464.

45. Rodríguez-Espíndola O, Rodríguez-Espíndola M, Rodríguez-Espíndola O, et al. Analysis of the Adoption of Emergent Technologies for Risk Management in Pharmaceutical Manufacturing. Technol Forecast Soc Change. 2022;174:121145. doi:10.1016/j.techfore.2021.121145.

46. Algorri M, Rantanen J. Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility and Flexibility. J Pharm Sci. 2022;111(9):2851–2859. doi:10.1016/j.xphs.2022.04.018.

47. Kausik AK, Kausik AK, Kausik AK. Machine Learning Algorithms for Manufacturing Quality Assurance in the Pharmaceutical Industry. Pharmaceutics. 2025;17(1):1–16. doi:10.3390/pharmaceutics17010001

Downloads

Published

2026-03-16

How to Cite

1.
Samanta S, Brahma PK, Rathi S. Advancing Quality Risk Management: A Comparative Overview of Traditional and Modern Tools in Pharma. J Neonatal Surg [Internet]. 2026 Mar. 16 [cited 2026 Mar. 17];15(1s):48-57. Available from: https://jneonatalsurg.com/index.php/jns/article/view/10094

Issue

Vol. 15 No. 1s (2026): Journal of Neonatal Surgery

Section

Original Article

License

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

You are free to:

  • Adapt — remix, transform, and build upon the material for any purpose, even commercially.

Terms:

  • Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
  • No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.