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History

The department was organized by order of the Ministry of Health of the Republic of Uzbekistan No. 177 dated May 31, 2013 pursuant to paragraph II.3.2. protocol decision of the meeting of the Cabinet of Ministers of the Republic of Uzbekistan No. 23 dated 10.04.2012

 

The activities of the department are aimed at introducing quality management systems harmonized with international standards at enterprises of the domestic pharmaceutical industry, providing them with scientific and methodological assistance, training qualified personnel for the industry.

In pursuance of paragraph 2.7 of the decision of the meeting of the Presidium of the Cabinet of Ministers of the Republic of Uzbekistan dated February 10, 2014 No. 12, the Uzstandard Agency determined the department as an authorized certification body for compliance with the approved national standards GMP, GCP, GLP, GDP and GSP, and also instructed the body to prepare a national inspectorate for the above standards.

During its existence, the department has carried out certification of domestic pharmaceutical manufacturers. A schedule for the phased implementation of the international GMP standard at pharmaceutical enterprises of the Republic of Uzbekistan in the period 2013-2017 was prepared and approved by the Cabinet of Ministers of the Republic of Uzbekistan. Together with the Uzstandard Agency, an action plan was approved to improve the practical implementation of internationally harmonized national standards GMP, GCP, GLP, GDP and GSP. More than 1,500 industry specialists were trained at the refresher courses at the department according to the above standards.

Under the Department for the coordination of the implementation of international standards in the pharmaceutical industry, a certification body for quality management systems "PHARMASTANDARDS" has been organized, which is successfully accredited in the Accreditation System of the Republic of Uzbekistan for the issuance of certificates for compliance with internationally harmonized standards. quality management systems "PHARMASTANDARDS", which is successfully accredited in the Accreditation System of the Republic of Uzbekistan for the issuance of certificates for compliance with internationally harmonized GMP standards; GDP; GSP; GCP; GLP (No.UZ.AMT.05.MAI.035 dated January 20, 2015).

In pursuance of the protocol decision of the Cabinet of Ministers of the Republic of Uzbekistan No. 23 dated April 10, 2012, by order of the Ministry of Health of the Republic of Uzbekistan No. 133 dated May 18, 2012, working groups were created for the development of projects, expertise, submission for registration and preparation of proposals for the practical implementation of State standards of the Republic of Uzbekistan, harmonized with international standards :

GMP - Good Manufacturing Practice;

GLP - Good Laboratory Practice;

GCP - Good Clinical Practice;



The developed State Standards were approved by order of the Ministry of Health of the Republic of Uzbekistan No. 42 dated February 13, 2013 and registered with the Uzstandard Agency under No.

GLP - O`zDSt 2762: 2013;

GSP - O`zDSt 2763: 2013;

GDP - O`zDSt 2764: 2013;

GDP - "Good Distribution Practice";

GSP - Good Storage Practice.

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