Introduction to the Management System of European Official Medicines Control Laboratories Network

Huang Baobin, Xu Mingzhe

Chinese Pharmaceutical Affairs ›› 2019, Vol. 33 ›› Issue (4) : 408-415.

Chinese Pharmaceutical Affairs ›› 2019, Vol. 33 ›› Issue (4) : 408-415. DOI: 10.16153/j.1002-7777.2019.04.010
Foreign Pharmacy

Introduction to the Management System of European Official Medicines Control Laboratories Network

  • Huang Baobin, Xu Mingzhe
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Abstract

Objective: To introduce the management system of European Official Medicines Control Laboratories Network (OMCL) in order to provide references for the management and capacity building of drug control institutes in China. Methods: The items about organization management such as the management of qualification, status assessment and member application of the European OMCL were discussed in great details based on the survey and reviews of the charters, regimes and technical guidelines about European OMCL issued by European Directorate for the Quality of Medicines (EDQM), as well as face-to-face communications with the staff of the European OMCL. Results and Conclusion: Under the unified coordination and leadership of the secretariat, the European OMCL has formed a rigorous and complete set of working procedures and assessment methods for qualification management and membership application to ensure that each member laboratory can completely fufill its responsibility according to the requirements of the European OMCL.

Key words

European Official Medicines Control Laboratories Network;European Directorate for the Quality of Medicines;qualification management and membership application

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Huang Baobin, Xu Mingzhe. Introduction to the Management System of European Official Medicines Control Laboratories Network[J]. Chinese Pharmaceutical Affairs, 2019, 33(4): 408-415 https://doi.org/10.16153/j.1002-7777.2019.04.010

References

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