In November 2010, a laboratory complex was created in the Central Federal District - the Kursk branch of the Laboratory for Quality Control of Medicines of the Federal State Budgetary Institution "Information and Methodological Center for Expertise, Accounting and Analysis of Circulation of Medical Products" of Roszdravnadzor
The testing laboratory (center) provides the following services:
- examination of the quality of medicinal products and excipients used for the preparation of medicines:
- pharmaceutical substances;
- semi-finished products and finished non-prepackaged medicinal products (angro);
- finished medicinal products;
- homeopathic medicinal products;
- medicinal plant raw materials;
- biologically active supplements.
- checking the adequacy and reproducibility of methods and techniques for quality control of medicines included in the regulatory documentation;
- providing technical assistance on the development and validation of quality control methods for medicines;
- information, marketing and consulting services in the field of medicines circulation;
- providing applicants with reagents, titrated solutions and indicators.
Structure:
- Analytical laboratory
- Microbiological laboratory
- Pharmacological laboratory
- Organizational department
Certificates:
Accredited for compliance with GOST ISO/MEK17025-2009 in the Russian national accreditation system - a unique record number in the Register of accredited persons No. ROSS RU.0001.21FM05
Accredited by the international accrediting body - American National Institute of Standards of the American Association for Quality (ANSI-ASQ National Accreditation Board - ANAB) for compliance with ISO/IEC 17025: 2017. Certificate of accreditation No.AT-2161 issued
License to carry out activities in the field of the use of infectious diseases of humans and animals and genetically modified organisms of III-IV degree of potential danger, carried out in closed systems (license number: 77.99.18.001.L.000039.03.11)
License for activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants No. FS-61-03-000021 dated 19.05.2020