[Batch testing as an essential pillar of the supply of safe and effective vaccines]. / Chargenprüfung als wesentliche Säule der Versorgung mit sicheren und wirksamen Impfstoffen.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
; 65(12): 1244-1250, 2022 Dec.
Article
in German
| MEDLINE | ID: covidwho-2280369
ABSTRACT
The Paul-Ehrlich Institute (PEI) plays a central role in the release of vaccines in Germany as well as Europe. The experimental testing and release of each vaccine batch is carried out according to the procedures and regulations of the Official Control Authority Batch Release (OCABR) and the German medicine act paragraph 32. The independent testing aims to demonstrate the conformity of quality criteria set in the marketing authorization for each lot produced. This article illustrates both the batch release procedure in general and specifically for the newly developed and approved COVID-19 vaccines during the COVID-19 pandemic.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Vaccines
/
COVID-19
Type of study:
Experimental Studies
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
Europa
Language:
German
Journal:
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz
Journal subject:
Public Health
Year:
2022
Document Type:
Article
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