Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

Autor: Samukange WT; BloodTrain, Paul-Ehrlich-Institut, Langen, Germany., Klümpers V; BloodTrain, Paul-Ehrlich-Institut, Langen, Germany., Kafere C; BloodTrain, Paul-Ehrlich-Institut, Langen, Germany., Schuler F; Division of Allergology, PEI, Germany., Tirane FJ; Zambia Medicines Regulatory Authority (ZAMRA), Lusaka, Zambia., Kabaso B; Zambia Medicines Regulatory Authority (ZAMRA), Lusaka, Zambia., Chama D; Zambia National Blood Transfusion Service (ZNBTS), Lusaka, Zambia., Ejeh EA; National Agency for Food and Drug Administration and Control (NAFDAC), Abuja, Nigeria., Reinhardt J; BloodTrain, Paul-Ehrlich-Institut, Langen, Germany; Division of Haematology and Transfusion Medicine, PEI, Langen, Germany. Electronic address: reije@pei.de.
Jazyk: angličtina
Zdroj: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 Nov; Vol. 68, pp. 125-128. Date of Electronic Publication: 2020 Sep 06.
DOI: 10.1016/j.biologicals.2020.08.012
Abstrakt: During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24 th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.
(Copyright © 2020. Published by Elsevier Ltd.)
Databáze: MEDLINE
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