Expansion of the GMP InspectorateОпубліковано 28.01.2020 о 10:06
The State Service of Ukraine on Medicines and Drugs Control (hereinafter – SMDC) is carried out certification of medicinal products production in accordance with the requirements of Good Manufacturing Practice (GMP). The SMDC is guided in its activities by the Law of Ukraine “On Medicines”, Regulation on the State Service of Ukraine on Medicines and Drugs Control, approved by the Cabinet of Ministers of Ukraine of August 12, 2015 No. 647, Procedure for confirming compliance with GMP requirements, approved by the Ministry of Health of Ukraine of December 27, 2012 No. 1130 (amended), the requirements of the PIC/S, of which the SMDC is a member, according to the Resolution of the Cabinet of Ministers of Ukraine of September 13, 2002 No. 1371 “The Procedure for the participation of Central Executive Bodies in International Organizations of which Ukraine is a member”.
In order to overcome the monopoly of carrying out inspections by one designated organization, to prevent the creation of artificial barriers such as waiting lists and to streamline the planning processes while carrying out inspections of medicinal products manufacturers for GMP compliance and to improve the procedure for confirming compliance of production conditions at the end of 2019, the SMDC has expand the register of GMP inspectors.
There are two state enterprises have been identified, whose GMP inspectors may be involved in the inspections: State Enterprise “Ukrainian Pharmaceutical Quality Institute”, State Enterprise “The Central Laboratory for Quality Analysis of Medicines and Medical Products”.
The qualification of GMP inspectors, included in SMDC’s Register of GMP inspectors, is confirmed in accordance with the requirements of the SMDC quality system. Applications expertise, in order to confirm compliance of manufacturing conditions with GMP requirements and sets of documents to them, procedures of preparation, inspection and registration of inspection results are carried out by state enterprises ” Ukrainian Pharmaceutical Quality Institute” and “The Central Laboratory for Quality Analysis of Medicines and Medical Products “, in accordance with the Procedure and internal quality system procedures that are equivalent to quality system SMDC procedures and meet the PIC/S requirements.