GxP
In order to ensure the coordination of work on state registration, standardization, certification of pharmaceutical products, technical regulation and the introduction of advanced foreign experience and international standards in the pharmaceutical industry, the Cabinet of Ministers of the Republic of Uzbekistan adopted a resolution "On additional measures to implement the requirements of good practice (GxP) in the pharmaceutical industry" dated August 3, 2021, No. 486. This resolution established the State Unitary Enterprise "Center for Good Practices" of the Agency for the Development of the Pharmaceutical Industry.
The main tasks of the Center are:
-organization of work on the implementation of international standards of good practices (GxP) at enterprises and organizations operating in the pharmaceutical industry;
-conducting pharmaceutical inspections to certify compliance with the requirements of good practices (GxP);
-ensuring the harmonization of local standards of medicines, medical devices and medical equipment manufactured in the Republic of Uzbekistan with international standards;
-coordination of international cooperation in the field of implementation of the international quality management system "ISO" and the Rules of Good Practice (GxP) in the processes of creation, production, regulation of circulation, quality control, technical regulation of medicines, medical devices and medical equipment;
-conducting inspections of the quality system in foreign pharmaceutical production sites and issuing a conclusion in the process of state registration of medicinal products in accordance with the established procedure.
In addition, in accordance with the Decree of the President of the Republic of Uzbekistan dated January 21, 2022 No.PD-55 “On additional measures for the accelerated development of the pharmaceutical industry of the Republic in 2022-2026”, it was established that:
-from April 1, 2022, new manufacturing enterprises, wholesale and retail organizations in the pharmaceutical industry are created in accordance with the requirements of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Pharmacy Practice (GPP);
-from January 1, 2023, only organizations that have organized the production of medicines - according to the standards of "Good Manufacturing Practice" (GMP), medical devices and medical equipment - according to the standards "ISO: 13485" are allowed to participate in tenders for public procurement of pharmaceutical products, as well as wholesalers that have implemented Good Distribution Practice (GDP) standards.
Also, the Decree provides for the following measures to support organizations involved in the production of medicines in accordance with the requirements of Good Manufacturing Practice (GMP):
provision until January 1, 2025 of subsidies to cover up to 50% of transportation by road and rail (excluding transportation costs) when exporting pharmaceutical products to all countries, including neighboring neighboring states, in an amount not exceeding 5% of the export value of products (with road transport) and 7% (railway transport);
provision of revolving loans to replenish the working capital of pharmaceutical exporting organizations when they export goods for up to 1 year at a rate of 4% per annum (taking into account the bank's margin) with the condition of deferred payments and in the amount of the value of exported products in the equivalent of not more than 3 million US dollars.
The main requirements of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Pharmacy Practice (GPP) are:
-quality management;
-requirements for personnel;
-requirements for buildings and equipment, premises and equipment;
-documentation;
-technological processes;
-quality control
-activities transferred to another organization (outsourcing)
-claims, quality defects and product recalls (claims, returns, suspicions of falsification and recall of medicines and medical devices from circulation);
-transportation;
-self-inspection.
The key benefits of implementing good practices (GDP, GMP, GPP) include:
-prevention of import of low-quality products;
-providing the population with high-quality, safe and harmless medicines;
-a clear definition of responsibility for ensuring the safety of pharmaceutical products;
-ensuring timely and high-quality fulfillment by employees of their duties;
-change in quality and safety indicators of pharmaceutical products, which slightly reduces the risk of defects and product recalls;
-documentary evidence of confidence in the safety of pharmaceutical products;
-creation of a quality system that meets the RSM;
-elimination of technical barriers in the implementation process;
-open a wide way for the export of domestic products to foreign countries, as well as ensure the consumption of domestic products;
-detection of falsified substandard drugs in the sampling chain;
-ensuring the delivery of pharmaceutical products to consumers without changing their properties;
-participation in tenders for public procurement of pharmaceutical products.
The list of enterprises that currently have a national certificate of compliance
with the requirements of "Good Practices (GxP)" is given in the following link: https://uzpharm-gxp.uz/ru/registry2/ https://uzpharm-gxp.uz/en/registry3