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Batch Packaging Record – A batch packaging record should be kept for each batch or part batch processed. The batch packaging record should contain the following information:
A Product name and batch number.
b. Date and time of packaging operation.
c. Identification of the operator who performed each critical step of the process and, where appropriate, the name of any person who checked these operations.
d Records of checks for identity and conformity with packaging instructions, including results of in-process controls.
e Details of packaging operations, including equipment used and packaging lines.
f Samples of printed packaging materials used, including batch coding, expiry date and additional overprint samples, whenever possible.
g Quantity and reference number or identification of all printed packaging materials and bulk products, issued, used, destroyed or returned to stock and the quantity of product received, to provide an adequate reconciliation.
h. Approval by person responsible for packaging operations.
