Zoekresultaten - 2 results

Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.

before filing of the MA application. The initial process involves the transfer of the analytical methods for those tests that will be performed by the OMCL. Regarding the set of the tests to be performed ...

Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).

tests already performed by the manufacturer need to be repeated by an OMCL (Official Medicines Control Laboratory) before a release certificate for this specific batch can be granted. In general, testing ...

QR code

QR code for this page URL