Release Documentation. The Batch/Lot Release Document Package will include a Certificate of Analysis and a Certificate of Compliance. A CoA will be provided and will include the name of the PRODUCTS, batch number, date of manufacture, and analytical specifications. The CoA will list the Release tests performed by Fresenius laboratories and actual test results.
Appears in 3 contracts
Sources: Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.)