Product Release. The Client will have sole responsibility for release of the Product to the market. When Patheon qualified person (“QP”) services are employed, Patheon QP may release the Product for distribution on behalf of the Client.
Product Release. 5.1. Product testing and disposition shall be performed by AMRI, however, the final approval shall be assigned by Sunesis before using the material for further processing and/or before releasing for any shipments. In the event that Sunesis takes more than thirty (30) business days to notify AMRI of its decision regarding the material, AMRI will have the right to xxxx Sunesis for such material to the extent agreed in the appropriate Work Order.
5.2. A Certificate of Analysis (COA), including a statement of Conformance to GMPs shall be generated for each lot produced. All data generated as part of the process and testing will be reviewed by AMRI QA (or a technically qualified AMRI employee not having direct responsibility for the processing activities). AMRI QA shall be the final signer of the COA and release of the product for shipment to Sunesis and/or designated location. The certificate will cover at a minimum the following information:
5.2.1. Description, AMRI item number or item name, lot/batch #, release date, manufacture date, retest/re-evaluation date. (Sunesis part number will be applied to the labeling of the shipping container.)
5.2.2. Conformance statement such as “The product was manufactured in compliance with GMPs, AMRI’s quality system, current procedures and specifications. This product meets specifications.”
5.2.3. Certificate of Analysis section to include a listing of the tests, specification, and result.
5.2.4. QA signature and date [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Product Release. 7.3.1 The following verifications are done prior to releasing product for distribution:
2.4-1. 002;
Product Release. Fresenius shall ensure and certify that the PRODUCT has been made in accordance with the Production Standards by reviewing all manufacturing and control information prior to release of the PRODUCT. Shipment of the PRODUCTS to TransMedics, once dispositioned as “released” by Fresenius and delivered to TransMedics’s carrier, is the responsibility of TransMedics’s quality department. Acceptance or rejection of released PRODUCT will be undertaken by TransMedics, based on TransMedics’s internal procedures (as set forth below), and the full document package provided by Fresenius, and completion of any release testing required by TransMedics Quality Assurance. Product Release Procedure
1. Fresenius will provide the following items to TransMedics Quality Assurance: – A Certificate of Analysis (COA), executed by Fresenius, confirming that the PRODUCT has been tested, and meets the registered specifications. Test specifications and test results must be included for each test. The COA shall also contain the information set forth in Appendix III; – A Certificate of Compliance (COC) (Not required if statement of cGMP compliance is on COA) executed by Fresenius stating the PRODUCT has been manufactured in accordance with the approved Batch record and listing all deviations and investigations related to the Batch and confirming that all deviations and investigations related to the Batch were completed in compliance with applicable SOP’s, and the Quality Requirements. The COC shall also contain the information set forth in Appendix III. – Any Quality-Analytical Investigation Report or any other significant deviation investigations related to the batch.
2. Upon receipt of finished product at its indicated distribution center, TransMedics QA will perform an appropriate statistical sampling of received product. The inspection will include verification of visual properties and label integrity.
3. Upon review of Fresenius documents, the TransMedics QA will either (i) reject the PRODUCT for non-conformance or (ii) accept the PRODUCT subject to its rights under the DEVELOPMENT AND SUPPLY AGREEMENT and issue authorization for distribution. Batch Record Review Procedure Validation batches: Fresenius is responsible for providing TransMedics with a validation package that includes: (1) the validation protocol, (2) full batch document packages, (3) all validation data and (4) validation report for all validation batches of the PRODUCT manufactured. TransMedics shall have the right to...
Product Release. Supplier quality unit has the responsibility to review and approve the executed batch production records prior to batch release. Supplier has the responsibility to release any products manufactured by Supplier for Client for shipment to Client. At the Client’s request, the executed batch production records will be sent to Client for review prior to batch disposition. Supplier will not ship any products manufactured for Client to any destination, as identified by Client, until the product(s) manufactured for Client is or are released for shipment, unless prior written approval has been received from Client to perform such a shipment under quarantine. Supplier is responsible for the issuance for each batch of product manufactured for Client a Certificate of Analysis and Certificate of Conformance (see also section 16).
Product Release. 6.1 Reliant shall only accept finished product that complies with the NDA or approved Supplement, and with the Manufacturing Agreement
Product Release. 7.1 Reliant is responsible for assessing final product disposition and release. Cardinal shall provide a COA/COC and product yield page for each lot manufactured.
Product Release. P-Com has Standards and Procedures defining the requirements for a uniform method of releasing a product and its technical documentation to manufacturing. The system also provides the method of controlling documentation during the engineering development cycle and construction of breadboard and/or prototype product. 8.4 DOCUMENT CONTROL - QAP 4.5(03.70.005)
Product Release. 10 7.4 Product Complaints and Recall......................... 10 7.5
Product Release. MERCK is responsible for final release of each lot of PRODUCT for sale within the TERRITORY in accordance with MERCK's standard practices. NASTECH is responsible for providing a copy of those MANUFACTURING records, as specified in the QUALITY AGREEMENT, for each lot of PRODUCT MANUFACTURED in support of MERCK's responsibility for final release decision.
