Question from: Pia Rudberg prudberg@nykode.com at 2024-10-08 14:46:08

1. Is QP certification the same as QP release?

2. Can you provide a description of what a QP release is and what the QPs check when they perform a QP release? (For Drug substance (DS), drug product (DP), and IMP)

3. Can you give some advice to small companies that don’t have their own QP on how to handle this? Assuming there are three different manufacturers (DS, DP, and IMP).
• How can QP responsibility be most appropriately outsourced?
• How should responsibility be organized? (QP, QP, QP-agreements. Who should release according to the IMPD, etc.)
• How do other companies organize this?

4. Given a situation where manufacturing, as well as labeling and packing, take place in Europe, but the IMPs are transported to the US for use in a clinical study in the US after release. We understand that a QP release for export in the EU can be done before the IMP are shipped to the US.
• What needs to be checked in the US and by whom after a QP release for export in the EU? Can the US use this type of release without further release?
• What does a QP release for export entail, and what is the difference between this release and a regular QP release for the EU?
• Are you familiar with the requirements for releasing IMPs in the US, and can you explain them? We understand that a QP release is not required, but what does a release in the US involve compared to a QP release in the EU?

5. Are you familiar with the requirements for IMP release for clinical trials in Asia, and can you provide some advice?

6. Are you familiar with the requirements for IMP release for clinical trials in Brazil, and can you provide some advice?