The State Service of Ukraine on Medicines and Drugs Control as a member of the international Pharmaceutical Inspection Cooperation System PIC/S has the obligation to constantly improve quality management systems, professional training and education of GMP inspectors, update the laws and standards of Ukraine in accordance with the requirements of EU legislation and PIC/S.
The State Service quality management system has recently passed a recertification assessment by PIC/S, including professional completeness and specialization of industrial inspectors. In the near future, a supervisory audit of the State Service Quality Management System is expected to check compliance with the requirements of the ISO 9001: 2015 Quality Management Systems – Requirements standard.
Now the State Service is preparing changes to the requirements of Good Manufacturing Practice, namely the following additions:
Appendix 2: Production of biological active substances and biological medicinal products for human use. Manual ST-N MZU 42-4.0: 2019 Medicines. Good Manufacturing Practice (Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use),
Appendix 17: Conducting tests for real-time release and release according to the parameters of the Manual ST-N MZU 42-4.0: 2019 Medicines. Good Manufacturing Practice (Annex 17: Real Time Release Testing and Parametric Release)
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
Manual ST-N MZU 42-4.0: 2019 Medicines. Good manufacturing practice (updating the guidance on the introduction of Part IV)).
In order to further harmonize the legislation of Ukraine with EU legislation and the requirements of PIC / S, together with the Ministry of Health of Ukraine, the State Service has developed draft orders of the Ministry of Health of Ukraine on changes in the procedure for confirming the compliance of the production conditions of medicines with the requirements of good manufacturing practice and the procedure for certification of the quality of medicines for international trade and confirmations for active pharmaceutical ingredients that are exported.
