In April 2012, a laboratory complex was created in the North-West Federal District - the St. Petersburg 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:
- substances and intermediates
- finished medicinal products (aerosols, eye drops, granules, pills, injection dosage forms, capsules, ointments, infusions and decoctions, tinctures, plasters, powders, syrups, suppositories, suspensions, tablets, extracts, emulsions, etc.);
- homeopathic medicinal products;
- medicinal plant raw materials and herbal medicinal products.
- checking 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 medicine circulation:
- on issues related to the development of quality control methods for medicines;
- related to the validation of quality control methods for medicines;
- for the standardization of medicinal products, reference materials.
- nonclinical (preclinical) laboratory studies of medicinal products in accordance with the requirements of the GLP OECD:
- determination of acute toxicity of the dosage form of the generic medicine and the reference medicine on one type of laboratory animals with the administration method specified in the instructions for medical use;
- comparative study of subchronic toxicity with the introduction of the generic medicine and the reference medicine for at least 14 days with the method of application specified in the instructions for medical use;
- GOST 32373-2013 (OECD Test No. 402) "Basic requirements for testing for the assessment of acute toxicity with cutaneous intake";
- GOST 32641-2014 (OECD Test No. 407) "Determination of toxicity in case of repeated/repeated oral intake of a substance in rodents. 28-day test ";
- GOST 32642-2014 (OECD Test No. 410) “Determination of toxicity in case of repeated/multiple cutaneous intake. 21/28-day test ";
- GOST 32296-2013 of November 22, 2013 (OECD Test No. 420) "Basic requirements for testing for the assessment of acute toxicity in case of intragastric intake by the fixed dose method";
-GOST 32644-2014 (OECD Test No. 423) "Acute oral toxicity - method for determining the class of acute toxicity"
Certificates
Accredited for compliance with GOST ISO/MEK17025-2009 in the Russian national accreditation system - a unique entry number in the Register of Accredited Persons: No.ROSS RU.0001.21ЛК50
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)
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 7. "