In September 2011, a laboratory complex was created in the Southern Federal District - the Testing Laboratory of the Rostov-on-Don 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:
- testing the quality of medicinal products and excipients used for the preparation of medicines:
- medicinal products: substances, finished non-prepackaged medicines (angro) and finished medicines (aerosols, eye drops, granules, pills, injectable dosage forms, capsules, ointments, infusions and decoctions, tinctures, plasters, powders, syrups, suppositories, suspensions, tablets, extracts, emulsions, etc.);
- medicinal plant raw materials;
- potent medicines.
- verification of the reproducibility of methods and techniques for quality control of medicines included in the regulatory documentation;
- providing applicants with reagents, titrated solutions and indicators;
- non-clinical (pre-clinical) studies of medicinal products in accordance with the requirements of the GLP OECD.
Certificates
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. АТ-1749 issued
Accredited for compliance with GOST ISO/IEC17025-2009 in the Russian national accreditation system - a unique entry number in the Register of accredited persons: RA.RU.21FL31
The testing center is recognized as complying with the principles of good laboratory practice, the requirements of the national standard GOST 33044-2014 "Principles of good laboratory practice" and the requirements of the Organization for Economic Cooperation and Development (OECD) for non-clinical research and is included in the Register of testing laboratories (centers) that comply with the principles of good laboratory OECD practice number 5
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 on the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants No. FS-61-000008 dated 20.04.2015
Included in the list of laboratories prequalified by the World Health Organization (WHO) for compliance with the requirements for testing laboratories
Certificate of Compliance of the Test Center with the principles of NLP issued by the Slovak National Accredited Service (SNAS) "Certificate of GLP compliance No. G-052"