Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities

Last updated on 22-8-2019 by Anonymous (non vérifié)

Sci. report, recommendat°, guidance doc., directive, monograph



Vaccine lot release conducted by the regulatory authorities is part of the regulation of vaccines and involves the independent assessment of each individual lot of a licensed vaccine before it is released onto the market. This assessment is based, as a minimum, on the review of manufacturers’ summary protocols. It may be supplemented by other documents such as the release certificate from the responsible National Regulatory Authority (NRA)/National Control Laboratory (NCL) and in some circumstances, by independent testing which is independent of the manufacturers’ quality control (QC) testi…

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