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Auditors experience with remote audits:Preparatory phase

(2022) Keywords: mutual joint audit mutual recognition OMCL Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des ...

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.

mutual recognition. Although the process of batch release in Europe is straightforward and clearly laid down in directives, it is sometimes a lengthy process. More than one year should sometimes be taken into account ...

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