Packaging operations
Article 30
1. The name and batch number of the product being handled shall be displayed at each packaging station or line. 2. Containers for filling shall be clean before being filled. Filling and sealing shall be followed as quickly as possible by labelling. If it is not possible, appropriate procedures shall be applied to avoid mix-ups or mislabelling. 3. The correct performance of printing operations (for example code numbers, expiry dates) shall be checked and recorded. Printed and embossed information on packaging materials shall be clear and resistant to fade or erasure. 4. Checks shall be made to ensure that any electronic code readers, label counters or similar devices are operating correctly. 5. Appropriate measures shall be implemented to avoid mix ups, such as storing and transporting cut labels and other loose printed materials in separate closed containers. Special care shall be taken when using cut-labels and when over-printing is carried out off-line. To avoid mix-ups, roll-feed labels are generally preferable to cut-labels. 6. The following controls shall be performed on the product during packaging operations: (a) general appearance of the packages; (b) whether the packages are complete; (c) whether the correct products and packaging materials are used; (d) whether any over-printing is correct; (e) correct functioning of line monitors. Samples taken away from the packaging line shall not be returned. 7. Any significant or unusual discrepancy observed during reconciliation of the amount of bulk product and packaging materials and the number of units produced shall be investigated and resolved before the release of the product. 8. Outdated or obsolete immediate packaging material or printed packaging material shall be destroyed and such disposal recorded. A documented procedure shall be followed if un-coded printed materials are returned to stock.