Introduction. The main factor in the global system of drug supply is the provision of important drugs that meet quality standards, safety, and should be at an affordable price. The document defining requirements to quality control of medicines is the standard of good manufacturing practice.
The standard of good manufacturing practice sets out the requirements for the proper production of medicines, active pharmaceutical substances used as raw materials. The implementation of the standard of good manufacturing practice in the pharmaceutical enterprises of the Republic makes it possible to monitor the process, the conditions of production, which directly affect the quality of dosage forms.
Objects and methods of research. Today, about 80 enterprises of the pharmaceutical industry of the country produce more than 11 thousand tons of medicines and medical products in the amount of 42.4 billion tenge per year, which, for example, is 37 times more than 20 years ago, in 1998 .
Since January 2016, the common market of medicines for the countries of the Eurasian economic Union has been functioning. At the same time, Kazakhstan has the highest level of imports of pharmaceuticals compared to other EAEU members. Thus, the share of imported pharmaceutical products in the market of Kazakhstan is 88%, in Belarus, for example, 75%, in Russia – 82%, given that according to the who recommendations, the share of domestic production should be at least 25% of the total volume of medicines in the country.
Results and discussions. Only medicines of GMP standard should be produced and sold on the territory of the EAEU. Standards of good pharmaceutical practices were approved in the system of state standard of the Republic of Kazakhstan in 2006. Since March 2014, all foreign companies exporting products to Kazakhstan had to confirm that they work according to the GMP standard, otherwise the import of their products into the country was prohibited. In 2015, GMP standards were updated to meet the requirements of the EU and the EAEU. Since January 1, 2018, GMP standards have made mandatory for Kazakh producers. Production facilities that have not yet implemented GMP may apply for safety and quality assessment of products and sell drugs before the expiration of their registration certificates .
The procedure of certification for compliance of a medicinal product with GMP standards in international practice is complex, and its main purpose is to confirm the safety and efficacy of products. In this regard, in order to achieve this goal, specialists of accredited certification organizations are not limited to the evaluation of a number of sample samples of medicines, as often provided by other standards. The procedure for establishing the required level of quality of medicines also includes the assessment of the enterprise itself engaged in its production. As a result, experts involved in certification procedures analyze a specific drug and the process of its release in the following areas:
assessment of production for compliance with safety criteria, including its verification of the probability of foreign impurities and substances entering the product;
• evaluation of production to meet technical requirements for production, including the conditions regarding humidity, temperature and other parameters in the production facilities;
assessment of the quality, safety and efficacy of medicines produced at a particular enterprise;
assessment of compliance of production parameters and characteristics of the drug with the regulatory documents adopted within the GMP procedure .
Conclusion. Manufacturers that have GMP certificate of conformity in Kazakhstan:
JSC "Himfarm" (SANTO company), LLP "VIVA Pharm», LLP "Petoleum», Too " Eikos Pharm», LLP "Kelun farm», LLP "Abdi Ibrahim global farm», JV "Ecofarm», Pharmaceutical company Romat LLP»
CJSC "Nobel Almaty pharmaceutical factory", etc .
A GMP facility must provide an environment for the safe processing and manipulation of tissues for use in humans under the new and stricter regulations. Its versatility in an academic center should allow for new protocols to be developed and readily applied in the ever changing and more demanding field of cellular and gene therapy.
- The business information centre Kapital.kz https://kapital.kz.
- Inform the BUREAU https://informburo.kz.
- Order of the Minister of health and social development of the Republic of Kazakhstan dated may 27, 2015 № 392. Registered in the Ministry of justice of the Republic of Kazakhstan on June 30, 2015 № 11506.
- Online magazine Attek experts https://www.centrattek.ru.