The Technical Expertise and Inspection Department at our Enterprise was established in August 2019, the main tasks of which are to conduct, on behalf of the State Medical Service, technical expertise and inspections of the conditions of manufacture of medicines in order to determine the compliance of medicines manufacture with the requirements of good manufacturing practice (GMP).
Our experts have many years of experience in conducting specialized expertise and inspections of domestic and foreign manufactures. The competence of our specialists is maintained at the appropriate level through continuous theoretical and practical training in accordance with international qualification requirements for GMP inspectors (PIC/S).
The quality of service, impartiality and provision of confidentiality are guaranteed by a quality management system that complies with the international standard DSTU EN ISO 9001:2018 “Quality management systems. Requirements” (EN ISO 9001:2015, IDT; ISO 9001:2015, ID) (see certificate).
We provide services on confirming compliance of medicines manufacture conditions with the requirements of good manufacturing practice and monitoring compliance with the requirements of good manufacturing practice by certified manufacturing site, as well as:
organization and conduct of inspections to confirm compliance of the conditions of manufacture of medicines with the requirements of good manufacturing practice (GMP) of the manufacturing site, located abroad;
organization and conduct of inspections to verify the implementation of the corrective and preventive action plan and documentary evidence;
organization and conduct of inspections to expand the range of medicines at sites that were previously inspected (making changes to the list).
Expertise of the application and a set of documents submitted to confirm compliance of manufacture conditions with GMP requirements, in particular:
- Expertise of the application for the issuance of an opinion in order to confirm compliance of the conditions for the manufacture of medicines with GMP requirements and a set of documents to it;
- Expertise of the application for the issuance of a certificate in order to confirm compliance of the conditions for the manufacture of medicines with the requirements of GMP and the set of documents to it;
- making changes to the list of product nomenclature attached to the conclusion/certificate confirming compliance of the manufacture of medicines with the requirements of good manufacturing practice, related to the expansion or narrowing of the product nomenclature;
re-issuance of a conclusion/certificate confirming the compliance of the manufacturer of medicines with the requirements of good manufacturing practice;
- making changes to the list of product nomenclature attached to the conclusion/certificate confirming compliance of the manufacturer of medicines with the requirements of good manufacturing practice, related to entering registration certificate numbers, names of medicines, dosages, etc.
In order to consult on the status of thIe consideration of cases and provide responses to comments on applications submitted as part of confirming the compliance of the conditions of production of medicines with the requirements of good manufacturing practice (receiving a conclusion, certificate, expanding the list) State Enterprise “Central Laboratory for Quality Control of Medicines and Medical Products” will hold consultations at:
8 V Kudryavska street, Kyiv
Reception days: Tuesday and Thursday from 13:30 to 16:30
Specialized expertise and inspections to confirm compliance of manufacture of medicines conditions with the requirements of good manufacturing practice are carried out in accordance with the Procedure for confirming compliance of manufacture of medicines conditions with the requirements of good manufacturing practice, approved by order of the Ministry of Health of Ukraine dated 27.12.2012 № 1130 (with changes).
price list for conducting an expertise of the application and a set of documents submitted to confirm compliance of manufacture conditions with GMP requirements.
If you have any questions, please use the feedback form or our contacts.