Arterium confirms compliance with manufacture licensing conditions
Kievmedpreparat passed the inspection for compliance with Medicinal Product Manufacture Licensing Conditions. The inspection was scheduled and carried out at the enterprise in February 2014.
Scheduled state control of operations of pharmaceutical manufacturers is performed by the State Administration of Ukraine on Medicinal Products at least once a year. This frequency is due to the fact that medicinal product manufacturers belong to high-risk enterprises. Recently, Ukraine has joined international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), which provides for implementation of European and international approaches to such inspections. The grounds for issuance of medicinal products manufacturing license include availability of relevant material and technical resources, qualified staff, as well as medicinal products quality control conditions.
“The inspection working with consideration of PIС/S recommendations highly appreciated manufacturing conditions, documentation and quality assurance system level in the work of our enterprise. This enables us to continue manufacturing products, majority of which, as a matter of fact, belong to the list of “Vital medicinal products”, Oleksandr Yatsiuk, Kievmedpreparat Executive Director, comments the inspection results.
We would like to remind that the requirements of Good Manufacturing Practice (GMP) (Guideline СТ-Н of the Ministry of Health of Ukraine 42-4.0:2013 “Good Manufacturing Practice”) compliant with GMP EU requirements are implemented into Licensing Conditions since August 2012.