Procedure for checking Online and Offline packing in pharmaceuticals

Procedure

• The programme for packing operations should aim at reducing the risk of mix up and cross contamination.
• Different products should not be packed in close distance unless there is a physical barrier or any other system which provides equal assurance
• Before starting packing operations the work area, packing lines, related equipment and printing machines should be clean and free from materials, products and documents.
• The line clearance should be done according to the procedures and checklist given.
• The packaging materials and products should be checked for identity, quantity and conformity in accordance with the instructions
• Product name and batch number that is handled should be notified at each packaging station
• Each packaging material should be given reference number or identification mark
• Containers for filling should be clean before filling. Any type of contaminants like metal or glass particles should be removed 
• After filling and sealing labeling should be done and if labeling is delayed then procedures should be followed to prevent mislabeling or mix up
• Printing of code numbers or expiry dates should be done separately and during the process they should be checked and recorded
• Printing which is done manually should be checked thoroughly at regular intervals
• In off-line and hand-packaging operations care should be taken when cut labels and over printing is done
• Roll- feed labels are preferred to cut labels to prevent mix-ups
• On-line verification of labels by automated electronic methods can prevent mix ups but they should be scrutinized so that electronic code readers and label counters are operating correctly
• When labels are attached manually in process control checks are done frequently
• Embossed and printed information on packing materials should be clear and resistant to erasing and fading
• On-line control of product should check on the following:
• General appearance of package
• Check whether packages are complete
• Checking if the correct products and packaging materials are used
• Checking if overprinting is correct
• Checking the functioning of the monitors
•  If any product is taken away due to unwanted events caused by it then it should be reintroduced only after thorough checking. A record of the event should be maintained.
• If any discrepancy is observed during reconciliation of packaging materials and bulk product then the number of units should be investigated and recorded before releasing.
• At the end of packing operation any unused packing materials if batch coded should be destroyed and also record should be available for the event.
• Unused materials should be returned to the stock 

Related documents:

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/cap5en.pdf

Checking on-line and off-line packing, product name, batch number, packaging station