EMA: Updated Q&As for Biological Medicinal Products
EMA’s Biologics Working Party has updated the question-and-answer document for biological medicinal products, adding information on nitrogen gas for backfilling, container closure systems and prior knowledge.
The new advice includes:
- Where nitrogen is used for backfilling (headspace gas), it should be included in the finished product composition as a footnote.
- The suppliers of of container closure systems for the sterile finished product(e.g. rubber stoppers and glass cartridges) should be named in the common technical document (CTD 3.2.P.7).
- Justifications based on prior knowledge should be included in the sections of the dossier where the product-specific data it is complementing or replacing would have been included.
The question on investigation of Low Endotoxin Recovery (LER) has been revised:
The updated response provides information on how to perform the studies, an adequate mitigation strategy, the handling of quality control samples, and the need to focus on the finished product.
Source:
EMA: Questions and answers for biological medicinal products
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