Zbigniew Fijałek, Katarzyna Sarna
Zarządzanie ryzykiem w wytwarzaniu i kontroli jakości produktów leczniczych
2009-03-25
In the European Union countries, registration of medicinal products and market authorization of medical devices is strictly connected with the quality of these products, safety and therapeutic effectiveness. The term quality includes such attributes as the identity, strength, purity and stability. At a European level the activities of the Official Medicines Control Laboratory (OMCL) Network is coordinated by the European Directorate for the Quality of Medicines (EDQM). EDQM is a Division of the Council of Europe. In the context of the General Network of Official Medicines Control Laboratory (OMCL) an OMCL is by status a public institution which only performs laboratory testing for a Competent Authority, independently from the manufacturer, for medicinal products prior to or after marketing for the general surveillance of medicines for the safety of human patient and animals. At a national level the OMCL contributes to the protection of public health and the regulatory function of Competent Authorities by providing independent analytical data on medicinal products that enable Licensing and Supervisory Authorities to make informed decisions on the quality of medicines.Keywords: Quality risk management, risk analysis, quality control, OMCL Network.
Zarządzanie ryzykiem w wytwarzaniu i kontroli jakości produktów leczniczych
359.16 kB |
21 grudnia 2017