During expertise of registration materials an expertise for compliance to requirements of good manufacturing practice must be evaluated for medicinal products that are submitted for new registration (renewal of registration), in the order specified by Ministry of Health.
GMP certificate is issued for manufacturing sites that have certificates from PIC/S will follow by simplified procedure of "recognition" of existing PIC/S GMP Certificate. Manufacturing sites without PIC/S GMP certificate must follow procedure with inspection.
Procedure of issue of Ukrainian GMP certificate for manufacturing sites that have PIC/S GMP is as follows: - filling the Application and dossier (list of necessary documents you can find below); - translation of the dossier into Ukrainian; - submission of the dossier to State Authority of Medicinal Products; - specialized expertise in authorized state organization; - issue of Conclusion that manufacturing site is PIC/S GMP certified; Sites that do not have PIC/S GMP Certificate must be inspected by Ukrainian inspectors.
Following documents must be submitted for GMP certification process:
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来自: 一土山人 > 《Pharmaceutical》