Features of risk analysis, assessment and control methods in pharmaceutical development

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Abstract

Quality Risk Management (QRM) is an important aspect of pharmaceutical development in the Quality-by-Design paradigm, since it determines the Design Space, critical quality attributes and critical process attributes.

The purpose of this review is to systematize and analyze the main aspects of the QRM system in relation to each element of pharmaceutical development. This review article discusses the following key elements of QRM such as: risk analysis, risk control, risk communication, risk verification. For risk analysis, the advantages and disadvantages of QRM tools such as Preliminary Hazard Analysis, Failure Mode Effects Analysis, Fault Tree Analysis are presented and analyzed, Hazard Operability Analysis and Hazard Analysis and Critical Control Points. In addition, a description of the methods of mathematical planning and design of experiments for pharmaceutical development and QRM is given and their significance for these systems is determined. Elements of QRM such as root cause analysis, brainstorming, and a corrective and preventive action procedure are given as risk control and mitigation tools.

In this paper, the main stages of QRM are considered and conclusions are formulated regarding the main advantages and disadvantages of the methods of identification, analysis, control, risk reporting, and the main ways for further improvement of the presented system are proposed.

About the authors

S. V. Tishkov

V.V. Zakusov Research Institute of Pharmacology

Author for correspondence.
Email: sergey-tishkov@ya.ru
ORCID iD: 0000-0002-8321-6952

Sergey Valeryevich Tishkov 

8 Baltiyskaya St., Moscow 125315, Russia

Russian Federation

E. V. Blynskaya

V.V. Zakusov Research Institute of Pharmacology

ORCID iD: 0000-0002-9494-1332

8 Baltiyskaya St., Moscow 125315, Russia

Russian Federation

K. V. Alekseev

V.V. Zakusov Research Institute of Pharmacology

ORCID iD: 0000-0003-3506-9051

8 Baltiyskaya St., Moscow 125315, Russia

Russian Federation

V. K. Alekseev

V.V. Zakusov Research Institute of Pharmacology

ORCID iD: 0000-0003-3542-0024

8 Baltiyskaya St., Moscow 125315, Russia

Russian Federation

References

  1. ICH Q8. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, 2005. 19 p.
  2. Food and Drug Administration CDER. Guidance for industry, Q8 (R2) pharmaceutical development. 2009. 25 p.
  3. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, ICH. Geneva, Switzerland, 2005. 20 p.
  4. Quality risk management (ICH Q9). 2011. EMA/INS/GMP/79766/2011. Available at: https://www.inspiredpharma.com/wp-content/uploads/2012/03/ich-9.pdf.
  5. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q10: Pharmaceutical Quality System. Geneva, 2011. 18 p.
  6. AS/NZS ISO 31000. Risk management – Principles and guidelines. International Organization for Standardization. 2009. Available at: http://globaltraining.edu.au/global_training_institute/Resource_Library/Australian_Standards/AS_NZS_ISO_31000-2009_Risk_management_-_Principles_and_guidelines.pdf.
  7. ISO 31000:2019 Risk management. Principles and guidelines. Moscow: Standartinform, 2020. 14 p. (In Russ.). https://pqmonline.com/assets/files/lib/std/gost-r-iso-31000-2019.pdf.
  8. Blynskaya E.V., Tishkov S.V., Alekseyev K.V. et al. Features pharmaceutical development lyophilisate GK-2 for parenteral use. Rossiiskiy bioterapevticheskiy zhurnal = Russian Journal of Biotherapy 2018;17(4):81–90. (In Russ.). doi: 10.17650/1726-9784-2018-17-4-81-90
  9. O’Malley P. Consuming risks: harm minimization and the government of ‘drug-users’. In: Governable places. Ed. by R. Smandych. Routledge, 2019. P. 191–214. doi: 10.4324/9780429427114-8
  10. Ferdosi M., Rezayatmand R., Molavi Taleghani Y. Risk management in executive levels of healthcare organizations: insights from a scoping review. Risk Manag Healthc Policy 2020; 13:215–43. doi: 10.2147/RMHP.S231712
  11. Cooper R.G. The drivers of success in new-product development. Industr Market Manag 2019;76:36–47. doi: 10.1016/j.indmarman.2018.07.005
  12. Okan S.Ü., Acar H.H., Gümüş S., Ergenç İ. Evaluation of the risks in wood harvesting activities by the preliminary hazard analysis (PHA). İleri Teknoloji Bilimleri Dergisi 2019;8(2):66–73.
  13. Subriadi A.P., Najwa N.F. The consistency analysis of failure mode and effect analysis (FMEA) in information technology risk assessment. Heliyon 2020;6(1):e03161. doi: 10.1016/j.heliyon.2020.e03161
  14. Press D. Guidelines for failure modes and effects analysis for medical devices. CRC Press, 2018. 190 p.
  15. Ruijters E., Stoelinga M. Fault tree analysis: a survey of the stateof-the-art in modeling, analysis and tools. Computer Sci Rev 2015;15:29–62. doi: 10.1016/j.cosrev.2015.03.001
  16. Signoret J.P., Leroy A. Hazard and operability study (HAZOP). In: Reliability assessment of safety and production systems: analysis, modelling, calculations and case studies. Springer, Cham, 2021. P. 157–164. doi: 10.1007/978-3-030-64708-79
  17. Gehring K.B., Kirkpatrick R. Hazard analysis and critical control points (HACCP). In: Food safety engineering. Ed. by A. Demirci, H. Feng, K. Krishnamurthy. Springer, Cham, 2020. P. 191–204. doi: 10.1007/978-3-030-42660-6_8
  18. Mazumder S., Pavurala N., Manda P. et al. Quality by Design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films. Int J Pharm 2017;527(1–2):151–60. doi: 10.1016/j.ijpharm.2017.05.048
  19. Jaberidoost M., Olfat L., Hosseini A. et al. Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods. J Pharm Policy Pract 2015;8(1):1–10. doi: 10.1186/s40545-015-0029-3
  20. Luciani F., Galluzzo S., Gaggioli A. et al. Implementing quality by design for biotech products: Are regulators on track? MAbs 2015;7(3):451–5. doi: 10.1080/19420862.2015.1023058
  21. Politis S.N., Colombo S., Colombo P., Rekkas D.M. Design of experiments (DoE) in pharmaceutical development. Drug Dev Ind Pharm 2017;43(6):889–901. doi: 10.1080/03639045.2017.1291672
  22. Rodríguez C., Ortiz I., Martínez I. Locally and maximin optimal designs for multi-factor nonlinear models. Statistics 2015;49(5):1157–68. doi: 10.1080/02331888.2014.922562
  23. Wichman K., Greenall J. Using root cause analysis to determine the system-based causes of error. Canadian Farm J 2006;139(3):63–5. doi: 10.1177/171516350613900314
  24. Peerally M.F., Carr S., Waring J., Dixon-Woods M. The problem with root cause analysis. BMJ Qual Saf 2017;26(5):417–22. doi: 10.1136/bmjqs-2016-005511
  25. Hussain T., Eskildsen J.K., Edgeman R. The intellectual structure of research in ISO 9000 standard series (1987–2015): a bibliometric analysis. Total Qual Manag Business Excellence 2020;31(11–12):1195–224. doi: 10.1080/14783363.2018.1469977
  26. ISO 14971:2007 Medical devices – Application of risk management to medical devices. (In Russ.).

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