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Application of Shewhart control charts when reviewing the quality of medicinal drugs

https://doi.org/10.21626/vestnik/2016-3/16

Abstract

The paper presents the application of Shewhart control charts in the annual review of medicinal products quality in order to analyze the production process stability and to use the indicators of process capability for the purpose of its enhancement. The authors presented the sequence of applying Shewhart control charts to identify the various states of manufacture processes and calculate reproducibility and suitability indices, enabling to interpret the input data for effective assessment of drug quality and proper management decisions. By example of some solid, liquid, and soft medicinal forms and by means of assessing the statistical characteristics used in drug quality review, we identified the possibilities of optimizing the production process, grounded the required management dicisions, confirmed the production process stability, identified the need for stabilizing the mean value, and established the causes of the production process uncontrollability.

About the Authors

M. R. Mtsariashvili
Kazan National Research Technological University
Russian Federation


S. Yu. Garmonov
Kazan National Research Technological University
Russian Federation


E. R. Sadykova
Public Corporation «Tatkhimpharmpreparaty»
Russian Federation


S. N. Egorova
Kazan State Medical University
Russian Federation


References

1. ГОСТ Р 52249-2009. Правила производства и контроля качества лекарственных средств. - Введ. 2009-06-08. - М. : Изд-во стандартов, 2009.

2. ГОСТ Р ИСО 7870-2-2015. Статистические методы. Контрольные карты. Часть 2. Контрольные карты Шухарта. - Введ. 2015-10-06 - М. : Стандартинформ, 2015.

3. ГОСТ Р 50779.44-2001. Статистические методы. Показатели возможностей процессов. Основные методы расчетов. - Введ. 2002-07-01 - М. : Изд-во стандартов, 2001.

4. Приказ Министерства промышленности и торговли от 14 июня 2013 г. № 916 «Об утверждении Правил организации производства и контроля качества лекарственных средств» [Электронный ресурс] // Гарант.ру. - Режим доступа: http://www.garant.ru/products/ipo/prime/doc/70351198/#ixzz3tBOfaRPZ, свободный (25.05.2016).


Review

For citations:


Mtsariashvili M.R., Garmonov S.Yu., Sadykova E.R., Egorova S.N. Application of Shewhart control charts when reviewing the quality of medicinal drugs. Kursk Scientific and Practical Bulletin "Man and His Health". 2016;(3):107-112. (In Russ.) https://doi.org/10.21626/vestnik/2016-3/16

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ISSN 1998-5746 (Print)
ISSN 1998-5754 (Online)