In May 2009, a laboratory complex was created in the Far Eastern Federal District - the Khabarovsk branch 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 types of services:
Testing the quality of medicines and excipients used for the preparation of medicines:
- medicines: substances, ready-made unpackaged medicines (angro) and ready-made medicines (aerosols, eye drops, granules, dragees, injectable dosage forms, capsules, ointments, infusions and decoctions, tinctures, patches, powders, syrups, suppositories, tablet suspensions, extracts, emulsions, etc.);
- medicinal products of pharmacy manufacture;
- medicinal plant raw materials;
- homeopathic medicines;
- semi-finished products and finished bulk medicines (Angro);
- narcotic, psychotropic substances and their precursors, potent medicines.
Verification of the adequacy and reproducibility of methods and techniques for quality control of medicines included in the regulatory documentation;
Information, marketing and consulting services in the field of medicines circulation:
- on issues related to the development of methods for quality control of medicines;
- related to the validation of medicines quality control methods;
Providing applicants with reagents, titrated solutions and indicators.
Structure:
Organizational Department
Analytical Laboratory
Microbiological Laboratory
Pharmacological Laboratory
Certificates:
Accredited for compliance with GOST ISO / IEC 17025-2009 in the Russian National Accreditation System-unique entry number in the Register of Accredited Persons No. ROCC RU. 0001. 21FL36
It is accredited by an 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. 2025 issued
License for the implementation of activities in the field of the use of infectious diseases of humans and animals and genetically modified organisms of the III-IV degree of potential danger, carried out in closed systems (license No.: 77.99.18.001. L. 000039. 03. 11)
License for the activity of trafficking in narcotic drugs, psychotropic substances and their precursors, cultivation of narcotic plants No. FS-61-000008 dated 20.04.2015