Certification of pharmaceutical products manufacturing

Certificate of conformity of the manufacturing conditions issued by the authorized body of the PIC/S member state is the official document certifying compliance of the manufacturing conditions of the pharmaceutical products with the requirements of good manufacturing practice (GMP). Ukraine has joined this international authorized body of cooperation between countries for the quality control of pharmaceutical products in 2011. Currently they already ensure productive cooperation regarding compliance with the requirements of good manufacturing practice (GMP), holding inspections and licensing manufacturing at a high professional level, and imposing high demands on the production of pharmaceutical products authorized for medical use in Ukraine. State Service of Ukraine on Medicines and Drugs Control issues a Certificate of Conformity that confirms compliance of the manufacturing conditions of pharmaceutical products with the requirements of good manufacturing practice (GMP).

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    Specialized evaluation of documentation and inspection may be delegated to other authorized organizations, but the right to issue the respective Certificate remains with the State Service of Ukraine on Medicines and Drugs Control. The procedure for issuing the Certificate includes: requesting the required documents, extensive analysis of the Site Master File, design documentation, SOPs and harmonization of documents with the current legislation. You will receive from us an objective evaluation of your documentation for manufacture and manufacturing site prior to the inspection from Ukraine. We may advise you to carry out a preliminary audit of the manufacturing site, obtain recommendations for removal of any discrepancies, and prepare САРА. We will then prepare and support the required documentation package for carrying out the procedure, including: filing the Application for issuing the Certificate, submission of the required documentation package, signing of the agreement, approval of the program and inspection plan, after payment for the expert services of the competent authority, carrying out the inspection, preparation of the report and issuing the Certificate of Conformity. In the event of substantial or immaterial comments, we will develop a strategy and prepare САРА for correction of the discrepancies and obtaining a Certificate.