Manufacturing Batch Records Clause Samples

Manufacturing Batch Records. Release test results and raw data for Drug Substance and Drug Product

Manufacturing Batch Records. 4.4.1 Bioniche shall also provide as part of the Batch Certificate of Analysis, a manufacturing compliance statement with each lot delivered to Cumberland. This certificate will certify that the lot of Product was manufactured in accordance with the Specifications and applicable cGMP laws or regulations. 4.4.2 The manufacturing lot records shall contain, at a minimum, the following information: • The name and dosage form of the medicinal product. • The batch number or test number of the API and all other raw materials (excluding water). • The date of manufacture and the Product’s batch number. • Details of the amounts of Product manufactured during each operation and the quantity of the Product in the various stages. • Both the expected and actual results of the in-process controls. If expected results are expressed in a quantified manner, actual results shall also be quantified. • Confirmation that the critical steps of the operations proceeded in accordance with the Manufacturing Instructions by the signature of the persons in charge of the various stages. • Special observations made during manufacturing. • Certification that the process operating lines have been cleared, at the beginning of the batch processing. • A list of deviations and their resolution. 4.4.3 Labeling of the product for Clinical Trials will be the responsibility of Cumberland.

Manufacturing Batch Records. Bachem shall maintain the manufacturing process and method information in its own format in manufacturing batch records.