Quality assurance

The Quality Service a team of highly qualified specialists with extensive experience in research work, which allows ensuring the high quality of work performed. Our specialists regularly undergo training in quality management, improving their qualifications, introducing in practice the latest methodology in the field of GxP.

Regulatory documents for work of the Quality Service:

The Federal Law №61-FZ of 12.04.2010 «On Circulation of Medicines».

The Order of the Ministry of Health of the Russian Federation of April 1, 2016, №199n «On the Approval of the Rules of Good Laboratory Practice»

Resolution № 81of EAEU “Concerning adoption of the Good laboratory practice of EAEU in the field of drug circulation”

GOST 33044-2014 “Principles of Good Laboratory Practice”

GOST 31883-2012 “Principles of Good Laboratory Practice (GLP). Quality assurance in the application of GLP principles”

GOST 7.32-2017 “System of standards on information, librarianship and publishing. The research report. Structure and rules of presentation”
Function of Quality Service:

In accordance with regulatory standards, there are three types of inspection defined by the quality assurance program:

  • Monitoring of studies;
  • Monitoring of experimental (research) center;
  • Monitoring of processes.

to monitor compliance with the regulatory requirements of the premises, equipment, personnel, methods and documentation.

The Quality Service has a documented Quality Assurance Program confirming the compliance with the principles of GLP.

About 150 standard operating procedures (SOP) have been developed and implemented in our organization. Work with SOP is ongoing. It is also possible to create SOPs for your requirements.

“RMC “HOME OF PHARMACY” always opens to monitoring and auditing of the research by various regulatory entities. Various audits of the “RMC “HOME OF PHARMACY” show that the organization complies with international quality standards for organizing and conducting preclinical studies according to the criteria of GLP.

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