Development of comprehensive solutions for managing the risks of a pharmaceutical enterprise while ensuring the quality of medicines based on a survey of specialists

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Abstract

Introduction. The guidelines do not suggest one true path to risk management. Pharmaceutical enterprises develop their own local regulations to ensure compliance with the regulations of the Russian Federation and the EAEU. There are very few studies on how domestic pharmaceutical enterprises solve the problem of introducing a quality risk management system into the enterprise’s quality management system. In this regard, work to study the functioning of the risk management system at Russian pharmaceutical enterprises seems extremely relevant.

Objective. Analysis of the activities of the risk management system for the quality of domestic pharmaceutical enterprises to identify systemic errors in its functioning and the subsequent development of methodological approaches to its improvement within the framework of compliance with current good manufacturing practices.

Materials and methods. Questionnaire method, descriptive statistics.

Results. According to the survey results, the majority of enterprises in the pharmaceutical industry (70.8%) have a system for monitoring and reviewing risks, which indicates a serious approach to risk management. However, almost a third of enterprises (29.2%) do not have such a system, which may indicate possible risks in quality management, as well as the need to implement such systems to ensure more effective control and reduce risks to drug quality. Some domestic enterprises (29.2% of responses) lack systems for monitoring and reviewing risks, which may indicate insufficient control over risks and lack of timely adaptation of the risk management system to changing conditions. The opinion of 52.3% of respondents that the risk management system at their enterprise is formal in nature indicates that the risk assessment system is currently not working effectively enough. The identified problems of the pharmaceutical industry in the field of risk assessment to ensure product quality are formulated: insufficient awareness of employees about some aspects of GMP rules, problems with the distribution of roles and responsibilities when carrying out routine procedures, insufficient theoretical training, inconsistency in the application of standards and procedures, low level of formality in risk assessment procedures, gaps in the understanding and application of risk assessment methods, lack of a systematic approach to monitoring and reviewing risks.

Conclusion. Based on the identified problems, the following proposals were developed to improve the quality risk management system at enterprises in the pharmaceutical industry.

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About the authors

Aleksandra Albertovna Taube

Saint-Petersburg State Chemical Pharmaceutical University of the Ministry of Health of the Russian Federation; Sechenov First Moscow State Medical University (Sechenov University)

Author for correspondence.
Email: Aleksandra.taube@pharminnotech.com
ORCID iD: 0000-0001-5594-4859

PhD in pharmaceutical sciences, associate professor at the Department of Economics and Management, Saint-Petersburg State Chemical Pharmaceutical University; Associate Professor, Department of Organization and Management in the Sphere of Circulation of Medicines, Institute of Professional Education, Sechenov First Moscow State Medical University (Sechenov University). 

Russian Federation, st. Professor Popov, 14, lit. A, Saint-Petersburg, 197376; Trubetskaya str., 8/2, Mosсow, 119991

Viacheslav Alekseevich Morozov

North Ossetian state University

Email: moroz36@yandex.ru
ORCID iD: 0000-0001-9228-6592

PhD in pharmaceutical sciences, associate professor, Head of the Department of Pharmacy

Russian Federation, Vatutina, 44–46, Vladikavkaz, North Ossetia – Alania, 362025

Geliya Nyazyfovna Gildeeva

Sechenov First Moscow State Medical University (Sechenov University)

Email: gildeeva_g_n@staff.sechenov.ru
ORCID iD: 0000-0002-2537-2850

PhD, Professor, Head of the Department of Organization and Management of Drug Circulation

Russian Federation, Trubetskaya str., 8/2, Mosсow, 119991

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Factors influencing the degree of formality in reviewing procedures lead to risk

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3. Fig. 2. Review of risks in relation to the objects of risk analysis

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4. Fig. 3. Criteria for choosing a risk analysis method at an enterprise

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5. Fig. 4. Risk assessment methods used in pharmaceutical enterprises, %

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6. Fig. 5. Leading role in conducting risk assessments at the enterprise

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7. Fig. 6. Determination of mandatory conditions established in pharmaceutical enterprises regarding risk assessment

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8. Fig. 7. Use of risk register in pharmaceutical industry enterprises

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9. Fig. 8. Assessment of the importance of risk factors influencing the determination of shelf life of solutions and reagents

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10. Fig. 9. Respondents' opinions on the effectiveness of the risk management system at pharmaceutical enterprises

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