Hi Erin,
The GMPs have accommodations for radiopharmaceuticals - take a look at leveraging those (for example, these products have pre- and post- release stages). I have seen pre-release of the drug delegated to the contract manufacturer, while the drug owner is involved in the final signature for post-release. There could be clauses of approvals in the case of significant deviations or OOS during the manufacture of the batch if necessary.
Hope that helps!
Kari
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Kari Frantzen MBA, BSc
Quality Manager
Vancouver BC
Canada
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Original Message:
Sent: 06-Oct-2020 16:37
From: Erika Butler
Subject: Radiopharmaceutical Drug Release
Section IV B 1. a. (page 7) of the Contract Manufacturing Arrangements for Drugs: Quality Agreements clearly states that the Owners of the drug are responsible for final release of the product. This creates an issue with Radiopharmaceuticals due to the short lifespan and the need to provide the product to the patient. For those that contract the manufacturing of radiopharmaceuticals, how have you dealt with this issue?
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Erika Butler
San Antonio TX
United States
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