Common use of Manufacturing Documentation Clause in Contracts

Manufacturing Documentation. 3.4.1 FRESENIUS KABI will maintain the batch identification system for the PRODUCT Manufactured by FRESENIUS KABI (i.e. batch number assignment) and ensure that unique batch numbers are used for each batch of the PRODUCT. X 3.4.2 FRESENIUS KABI will compile the BOM for PRODUCT Manufacturing with CSI’s final approval. X X 3.4.3 FRESENIUS KABI will maintain all batch records and associated PRODUCT documentation for a minimum of one year beyond expiry date of the PRODUCT. FRESENIUS KABI shall keep validation batch production and testing records permanently. X 3.4.4 FRESENIUS KABI will ensure executed batch records contain the following information to meet Device History Record (DHR) requirements. • Dates of manufacture; • Quantity manufactured; • Quantity released for distribution; • Acceptance records which demonstrate the device is manufactured in accordance with the DMR; • The primary identification label and labeling used for each production unit; and • Any identification(s) and control number(s) used. X 3.4.5 FRESENIUS KABI will draft and approve master Manufacturing batch records. X 3.4.6 FRESENIUS KABI shall Manufacture the PRODUCT in accordance with principles of cGMP as described by the Regulatory Authority appropriate for the type of PRODUCT. X 3.4.7 FRESENIUS KABI shall assure that the PRODUCT is Manufactured, Packaged, held, labeled, and tested according to FRESENIUS KABI’s procedures and batch records and fulfills the PRODUCT Specification. X