Quality control of biomedical cellular products
The order of conducting selective quality control of biomedical cellular products (BMCP) was approved by the Ministry of Health of the Russian Federation. The corresponding order of the Ministry of Health dated 27.03.2018 №127n was approved by the Ministry of Justice of Russia on April 5.
Roszdravnadzor conducts selective quality control of biomedical cellular products.
Selective quality control of the BMCP includes:
– processing of information that is obligatory provided by the subjects of circulation of the BMCP, about series and batches of BMCP coming into circulation in the Russian Federation;
– sampling of BMCP from subjects of their circulation in order to conduct tests for their compliance with the requirements of regulatory documentation;
– decision making of the further circulation of the relevant BMCP based on the tests results;
– the adoption of the decision to transfer the BMCP to the selective quality inspection in the case of repeated detection of its non-compliance with the requirements of the regulatory documentation for the BMCP and (if necessary) on the verification of the subject of treatment of the BMCP.
The costs connected with conducting a selective quality sampling of the biomedical cellular product are paid by the manufacturer of this product or by the owner of the registration certificate.
To conduct tests of the BMCP for compliance with the requirements of regulatory documents within the framework of selective quality control, Roszdravnadzor involves Federal State Budgetary Institution “Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products”, Roszdravnadzor.