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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.
OMCL will issue a certificate of compliance, or in case of unsatisfactory test results, a certificate of non-compliance. The issuing of a non-compliance certificate is a rare event under normal ...
Release testing by manufacturers & Ph.Eur. compliance: lessons learnt for competent authorities. A case study: the Extractable Volume
study case-study compliance meeting Release testing study TESTING Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin Efficacité et sécurité des vaccins, ...