Quality Management in Pharmaceutical Development of Biotechnology-Derived Medicinal Products: Implementation and Evaluation

SCIENTIFIC RELEVANCE. One of the challenges associated with the development of medicines lies in creating a quality management system (QMS) and tools to assess its performance.

AIM. The study aimed to propose a QMS model for the development of biotechnology-derived medicinal products and a performance evaluation tool for this QMS universally applicable in the research centre of the company regardless of the specific activities of its individual divisions.

MATERIALS AND METHODS. The study analysed internal audit outcomes, noncompliance responses, and the document flow of the research centre. Parameter values for quality index (QI) calculations were entered into validated Microsoft Excel spreadsheets. Data analysis and visualisation involved using the Microsoft Power Business Intelligence (BI) business analytics platform (mainly, the Power BI Desktop and Power BI Service components).

RESULTS. The QMS was implemented, and the authors proposed their QMS performance evaluation tool universally applicable to all the divisions of the research centre. CONCLUSIONS. The authors proposed their QMS model for the development of biotechnology-derived medicinal products and the QI tool for collecting digital data, carrying out standardised monitoring, and tracking QMS status changes. The QI tool is universal for all company departments regardless of their requirements, easy to use, and customisable by adding individual company-specific quality parameters. This makes the QI tool applicable not only to drug development departments but also to other research units.

1. Fisher AC, Lee SL, Harris DP, Buhse L, Kozlowski S, Yu L, et al. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality. Int J Pharm. 2016;515(1–2):390–402. https://doi.org/10.1016/j.ijpharm.2016.10.038

2. Li TW, Tu PW, Liu LL, Wu SI. Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan. Biomed Res Int. 2015;2015:670420. https://doi.org/10.1155/2015/670420

3. Ravinetto R, Roosen T, Dujardin C. The Belgian commitment to pharmaceutical quality: a model policy to improve quality assurance of medicines available through humanitarian and development programs. J Pharm Policy Pract. 2018;11:12. https://doi.org/10.1186/s40545-018-0136-z

4. Jampilek J, Crowley PJ, Olsen M, Tam K. Modern approaches to quality assurance of drug formulations. Biomed Res Int. 2015;2015:126478. https://doi.org/10.1155/2015/126478

5. Bereda G. Quality assurance and quality control. Current furtherances and hereafter point of view. J Anal Pharm Res. 2021;10(5):212–5. https://doi.org/10.15406/japlr.2021.10.00386

6. Kushare S, Darekar A, Saudagar R. Quality assurance and quality management in pharmaceutical science and pharmaceutical industry. J Drug Deliv Ther. 2019;9(2-S):537–42.

7. Haleem RM, Salem MY, Fatahallah FA, Abdelfattah LE. Quality in the pharmaceutical industry — A literature review. Saudi Pharm J. 2015;23(5):463–69. https://doi.org/10.1016/j.jsps.2013.11.004

8. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Understanding pharmaceutical quality by design. AAPS J. 2014;16(4):771–83. https://doi.org/10.1208/s12248-014-9598-3

9. Lee SH, Kim JK, Jee JP, Jang DJ, Park YJ, Kim JE. Quality by Design (QbD) application for the pharmaceutical development process. J Pharm Investig. 2022;52:649–82. https://doi.org/10.1007/s40005-022-00575-x

10. Zagalo DM, Silva BMA, Silva C, Simões S, Sousa JJ. A quality by design (QbD) approach in pharmaceutical development of lipid-based nanosystems: A systematic review. J Drug Deliv Sci Technol. 2022;70:103207. https://doi.org/10.1016/j.jddst.2022.103207

11. Testas M, Sais Tda C, Medinilha LP, Niwa KNI, de Carvalho LS, Maia SD, et al. An industrial case study: QbD to accelerate time-to-market of a drug product. AAPS Open. 2021;7:12. https://doi.org/10.1186/s41120-021-00047-w

12. Weitzel J, Pappa H, Banik GM, Barker AR, Bladen E, Chirmule N, et al. Understanding quality paradigm shifts in the evolving pharmaceutical landscape: perspectives from the USP quality advisory group. AAPS J. 2021;23(6):112. https://doi.org/10.1208/s12248-021-00634-5

13. Mantus D, Pisano DJ, eds. FDA Regulatory Affairs. London: CRC Press; 2014. https://doi.org/10.1201/b16471

14. Patravale VB, Disouza JI, Rustomjee M, eds. Pharmaceutical product development. Insights into pharmaceutical processes, management and regulatory affairs. Boca Raton: CRC Press; 2016. https://doi.org/10.1201/b19579