Cleaning Validation. Fresenius is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. The cleaning process will be validated before the first PRODUCT Batches are made for TransMedics. TransMedics shall review the cleaning validation on an audit basis. Data should be available to support the campaign of batches of the same product, and the type of cleaning that will be performed in between manufacturing of the same product.
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.)