Certification

This group of services includes:

✓ Evaluation of the safety and quality of drug products and medical products carried out through the Republican State Enterprise on the right of economic management “National Center of Expertise of drug products, medical devices and medical equipment of the Ministry of Health of the Republic of Kazakhstan

1) Evaluation of the safety and quality of the serial evaluation of the safety and quality of drug products that have GMP conformity certificates, medical devices that have certificates of compliance with the quality management system requirements for the manufacture of medical devices ISO 13485, GMP;

2) Evaluation of the safety and quality of each lot (batch) of products. In the case of continuous production, the lot corresponds to a certain part of products. Lot size in this case is determined either by a fixed quantity or by the quantity produced over a certain period of time;

3) Declaration of the safety and quality of drug products produced in GMP countries under the conditions of ICH region, GMP of the Republic of Kazakhstan, medical devices manufactured under EN ISO 13485, GMP in ICH regional countries.

✓ Confirmation of conformity services for all industries