Integrated quality management system: current issues of adaptation and implementation in the pharmaceutical industry of Kazakhstan.

Authors

  • G. Mukhanova Казахский экономический университет им. Т. Рыскулова
  • A. Makhatova Казахский экономический университет им. Т. Рыскулова

Keywords:

the system of quality support, integrated system of quality management, GMP (Good Manufacturing Practice), quality, safety of medicines,

Abstract

Approaches to their implementation at a pharmaceutical enterprise. Approaches to the implementation of integrated management systems at pharmaceutical enterprises, comparative analysis of standards used in development of integrated management systems at pharmaceutical enterprises, and main advantages observed after implementation of the integrated management systems are presented in the article. It is also proved that quality management today is a visit card of every pharmaceutical enterprise in its products launch. In the context of forced industrial-innovative development of Kazakhstan’s economy is very important in the formation of pharmaceutical enterprises policy compliance with international standards of production. It meets the strategic goals of the state for the safety of the country in various forms, including economic and pharmaceutical. It is also possible to improve the competitiveness of pharmaceutical companies in Kazakhstan by joining the global trend - the introduction of an integrated quality management system. Successful experience in the development of pharmaceutical companies - the leaders of the world economy clearly proves it. Improvement of the management system - an endless process, it is open to meet new challenges in a changing environment and provides stability and dynamic development of the company.

References

1 Александров А.В., Люлина Н.В., Барабанова В.Д. Построение интегрированных систем менеджмента фармпредприятия (I часть) // Ремедиум. – 2007. – №12. – С. 58–60.

2 Брагин В.В., Корольков В.Ф. Управление организацией. Стратегия развития бизнеса. С. 42.

3 Barbara K. Immel A Brief History of the GMPs for Pharmaceuticals // Pharmaceutical Technology. – July 2001 www.pharmaportal.com.

4 ГОСТЫ:- Р 52249-2009 «Правила производства и контроля качества лекарственных средств»;
- ГОСТ Р 52537-2006 «Производство лекарственных средств. Система обеспечения качества. Общие требования»;
- ГОСТ Р 52550-2006 «Производство лекарственных средств. Организационно-технологическая документация».

5 Миланич И.В., Гаффорова Е.Б., Меркушова Н.И. Система правления как конкурентное преимущество: монография. - Владивосток: Изд-во ТГЭУ, 2011. – 216

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