EMA: Updated Q&As for Biological Medicinal Products
EMA has updated its Q&A on biological medicinal products, addressing topics that previously required clarification or were subject to differing interpretation. The latest revision adds six new questions and updates several existing answers.
The changes clarify, among other points, how unexpected deviations in safety-critical in-process controls should be addressed in the dossier. Additional updates cover sample requirements for bioburden testing, potency assignment in reference standard qualification protocols, definition of the vaccine manufacturing date, and revised guidance on low endotoxin recovery, Antibody Dependent Cell-mediated Cytotoxicity (ADCC) testing specifications, and information needed on recombinant excipients.
Source:
EMA: Questions and answers for biological medicinal products
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