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. 6.1 Reliant shall only accept finished product that complies with the NDA or approved Supplement, and with the Manufacturing Agreement
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
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. 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. 10 7.4 Product Complaints and Recall......................... 10 7.5
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. 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.
Product Release. ICOS and PDL will each identify a Quality Assurance representative who will function as the points of contact between the companies for the purposes of communication regarding Product release and regulatory compliance activities. ICOS will source raw materials and components to be used in the manufacture of the Product and will ensure that approved specifications are in place. PDL will determine in-process, release and stability specifications for the Product. ICOS and PDL will mutually agree on these testing specifications for the Product. The parties will mutually agree in writing to all changes to specification before implementation. ICOS may subcontract some or all of the Product testing, subject to prior written approval by PDL. ICOS is responsible for control and monitoring of the Product manufacturing process and production facility. ICOS is responsible for reviewing Product lot records, test results against specifications and determining whether to reject the lot or issue a manufacturer’s release to PDL-QA. PDL-QA is responsible for the final release of each Product lot. ICOS will issue a Certificate of Analysis and Certification of Compliance to PDL for each lot that receives a manufacturer’s release. The Certificate of Analysis will contain a summary of the Product test results, specifications, and date of manufacture. The Certificate of Compliance will contain a statement signed by ICOS’ QA representative stating that the lot has been manufactured and tested in compliance with cGMPs, ICOS procedures and applicable guidelines. PDL may request additional documentation to support its review and release of Product lots, including but not limited to copies of Batch Production Records, raw data from Product testing and in-process test results. Environmental monitoring data is available for on site review. PDL will make reasonable efforts to release each lot within [*] of receipt of the Certificate of Analysis, Certificate of Compliance and documents listed in the scope of services. ICOS will store and ship the Product according to written PDL instructions and in compliance with cGMP. ICOS will ship Product only upon PDL’s approval. PDL is responsible for retaining samples from each lot for testing in accordance with cGMP. ICOS will provide retain samples to PDL as identified in the production batch records.
Product Release. 5.1 Product testing arid disposition shall be performed by AAIPS; however, Sunesis shall assign the final approval before using the material for further processing and/or before releasing for any shipments.
