Finished Product Testing. (a) You shall establish procedures for final acceptance of Finished Products to assure conformance to the Specifications and these Requirements. (b) You shall complete a Certificate of Analysis (COAs) in accordance with Exhibit E of the Agreement for each Batch. COAs shall be sent electronically to the individuals designated by the Customer for approval prior to release of the Batch for delivery. You shall not release the Batch until you receive the Customer’s approval of the COA. (c) When exceptions to the required process described in paragraph (b) above are deemed necessary, such exceptions must be documented in the form of an exception plan and mutually agreed upon. in advance with Customer. (d) You shall randomly select retain samples of the Finished Product that are representative of each Batch. These samples shall be stored under conditions that will preserve the Finished Product for maintenance of the traceability, integrity and Quality of the samples for at least two times the established shelf life of the Finished Product or one year, whichever is shorter, after delivery. (e) You also shall randomly select samples of the Finished Products that are representative of each Batch and ship them to Customer on the same Business Day as the electronic transfer of the COA The Batch and other relevant Quality and traceability information shall be included on the label of each sample. Each sample shall be packed in a manner that preserves its integrity and quality during transport to the Customer.
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Sources: Manufacturing Agreement (Kimree, Inc.), Manufacturing Agreement (Kimree, Inc.)