Question from: Silke Binninger Silke.Binninger@miltenyi.com at 2024-10-08 16:36:31

3. QP-Release

a) How to ensure the 2-release process for a fresh CART cell product with a shelf-life of 24 h?
• When the sponsor delegates this to the manufacturer (with an clear agreement between manufacturing and sponsor) – What information/documents should be made available to the manufacturer to ensure regulatory release by the manufacturer?
• How far in advance can this information be made available if there are no changes to the regulatory status?
• In this case, can the regulatory release also be issued by the QP on one batch certificate document?
• Is the filing of all required documents in the Product Specification File sufficient? Or is it required to send the documents via email to the manufacturer in order to assure the date of transmission to the manufacturer?
b) In the case that the Clinical Sites are in Japan, Manufacturing will be done in the US and the Management of the trial will be done in Germany – is it required to take all requirements of Germany under consideration as well (e.g. QP-release)? Or are only the location of the Clinical Sites and the Manufacturing required for the determination of the regulations to be used? How to deal with OOS – shall the IMP already being transported (“under quarantine”)?