Packaging Operations:
16.25 When the programme for packaging operations is being set up, particular attention should be given to minimizing the risk of cross-contamination, mix ups or substitutions. Different products should not be packaged in close proximity unless there is physical segregation or an alternative system that will provide equal assurance.
16.26 Before packaging operations are begun, steps should be taken to ensure that the work area, packaging lines, printing machines and other equipment are clean and free from any products, materials or documents used previously and which are not required for the current operation. The line clearance should be performed according to an appropriate procedure and checklist, and recorded.
16.27 The name and batch number of the product being handled should be displayed at each packaging station or line.
16.28 Normally, filling and sealing should be followed as quickly as possible by labelling. If labelling is delayed, appropriate procedures should be applied to ensure that no mix ups or mislabelling can occur.
16.29 The correct performance of any printing (e.g. of code numbers or expiry dates) done separately or in the course of the packaging should be checked and recorded. Attention should be paid to printing by hand, which should be rechecked at regular intervals.
16.30 Special care should be taken when cut labels are used and when overprinting is carried out off-line, and in hand-packaging operations. Roll-feed labels are normally preferable to cut labels in helping to avoid mix ups. Online verification of all labels by automated electronic means can be helpful in preventing mix ups, but checks should be made to ensure that any electronic code readers, label counters, or similar devices are operating correctly. When labels are attached manually, in-process control checks should be performed more frequently.
16.31 Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing.
16.32 Regular online control of the product during packaging should include at a minimum checks on:
(a) The general appearance of the packages;
(b) Whether the packages are complete;
(c) Whether the correct products and packaging materials are used;
(d) Whether any overprinting is correct;
(e) The correct functioning of line monitors.
Samples taken away from the packaging line should not be returned.
16.33 Products that have been involved in an unusual event during packaging should be reintroduced into the process only after special inspection, investigation and approval by authorized personnel. A detailed record should be kept of this operation.
16.34 Any significant or unusual discrepancy observed during reconciliation of the amount of bulk product and printed packaging materials and the number of units produced should be investigated, satisfactorily accounted for, and recorded before release.
16.35 Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed and the destruction recorded. A documented procedure requiring checks to be performed before returning unused materials should be followed if uncoded printed materials are returned to stock.
16.36 Production records should be reviewed as part of the approval process of batch release before transfer to the authorized person. Any divergence or failure of a batch to meet production specifications should be thoroughly investigated. The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure or discrepancy. A written record of the investigation should be made and should include the conclusion and follow-up action.
WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles
(Annex 2, WHO Technical Report Series 986, 2014)
