Packing scenarios Flashcards
Rogue tablet discovered by one of your packaging lines. 6 batches of product in campaign –
3 on market and 3 in warehouse. Next steps
a. Rogue product is digoxin – manufactured at another site, but packed at yours
b. Tablet size and shape, means it can fit into the blister pack for your current product
and the camera detection system won’t differentiate between rogue and intended
product
c. Digoxin was packed on the line 6 months ago
d. Stock costs over £1 million. MD wants it shipped now and is applying pressure
e. What would you say to him?
Name parties you need to involve with recall decision of this type
Raise Deviation Investigation
Quarantine all stock ran on this packing line in the last 6 months which is still in your control, notify any distributors to temporarily hold stock that hasn’t reach patient.
Stop packing Activities on this packing line.
Inform MD that root cause needs to be established prior to releasing any of the stock
What product is currently being packed?
Review Batch records – specifically line clearance, check of incoming materials, any deviations, interview operators ( Are any operators on this medication),
Where was the tablet found?
Complaints history
Risk of Market stock out? Possibly re-work if tablets I visually different
Your packaging line has a leaflet reconciliation error where you have more leaflets than you should. What are your concerns?
What documents would you look at?
You find there are several issues on the equipment over the past weeks – what are you concerned about the product and what are your recommendations?
The batch has to go today and the production manager asks is there anything you can do?
Insufficient line clearance and possible rouge leaflets within batch
Leaflets may not have been inserted into cartons
Supplier issue – more leaflets supplied than expected quantity
Line controls not working correctly
What is the scope of the issue
MBR - Line Clearance, Reconciliation calculations, IPC’s , Receipt to Line
SOP for reconciliation – (Is it done by weight or via a counter)
Retain / reference Samples
Check weigh – missing leaflet detector
Pharma-code Reader – check it is working
Supplier complaints – determine if issue has happened before
What was the issue?
Missing or Incorrect Leaflet, what other controls in place?
Recommendations would be based on the outcome of the investigation – how we can confirm if leaflet is present and correct. What the product is, criticality, if online leaflet is available, market status (eg stock outs)
Possible options to re-work batch
Caution in Use DMRC – online leaflet
Raise deviation put CAPA’s in place
