Scenario - Rogue Tablet
A rogue tablet is found in one batch of a 10 batch run. Five batches are out in the market and four are in the warehouse - now what?
As ever, an approach….
First thought
You are immediately concerned that a patient may be getting the wrong medication and it could potentially impact a lot of product.
Where did you/we find it?
Orientate & establish more detail
The focus of the scenario as currently presented can shift radically depending on where the rogue is found - simply because it may drive your root cause to a different finding which may in turn uncover the level of patient risk.
The first question is then logically - where did we find the rogue?
Sub scenario 1
The tablet is reported in a phone call or email from the market from either a customer or a pharmacist or patient.
This creates a need to establish if an external source is possible - i.e. its not your product that has appeared in your product container. You need to try and establish if the customer or pharmacist may have mixed up the tablet in a location outside your direct control.
This isn’t about trying to find a get-out-of-jail “not my companies problem” answer, but it’s to stop you going off down a blind alley.
Actions in this case may include:
Raising a complaint record within your QMS
Document complaint and complainant details (contact details, batch number etc)
Document initial actions such as quarantine of current stock.
Review QMS to see if similar complaints have been seen before.
Record either images of the rogue tablet or request shipment of the tablet to a facility you control for identification.
Sub scenario 2
The tablet is picked up on the packaging line. It could be either the correct product that has an altered appearance or possibly a different tablet that you make that is mixed in with the intended product.
Actions in this case may include:
Raising a deviation record within your QMS to:
Document the relative tablet types and where it has been found
Investigate when the rouge was last made, what sources of mix up could occur?
The fact that tablet is picked up on the packaging line begs a question in this instance. How was it found? Does you existing control strategy have a high confidence of detecting a rogue?
If this is a rogue that is visibly distinct enough and you can demonstrate your vision system will reliably detect its presence your risk profile from this issue might alter.
Sub scenario 3
The tablet is picked up in your QC labs when a blister or bottle has been opened. Again, it could be either the correct product that has an altered appearance or possibly a different tablet that you make that is mixed in with the intended product.
Actions in this case will be similar to the second scenario but it may be recorded as an OOS for appearance.
The key elements of extent and risk shift a little relative to sub scenario 2 - this chance detection in QC suggest that your on-line controls do not detect a rogue and you may have stumbled on the mix up by chance.
How would you handle this?
In either case there are several common actions and processes that should be discussed and documented within the relevant QMS record:
Risk assessment based on clinical risk. This will involve liaison with your clinical team and QPPV. What is your tablet? What does it treat and how? What is the risk to a patient if they unknowingly consume the rogue tablet instead of your tablet? You will also have to consider the risk of a recall to patients - can your patients or customers continue treatment and remain well if your product is taken off them? These are real and challenging questions and they do happen - see here for a recent example of a class 2 recall with this dilemma.
Investigate root cause. Once you establish where the rogue has appeared you can start to examine how it my have gotten mixed up.
Review your QMS to establish if this is a one off or is it a reoccurring issue - this will help shape the CAPAs you will propose.
Document initial actions such as quarantine of current stock.
What do you do?
Again this is not the only answer and the core response (recall or not) will vary on the details you uncover. But for a start:
Until you know more, you will need to stop certification - this falls in line with obligations under Annex 16 - specifically section 1.7.17 which states “Any on-going complaints, investigations or recalls do not negate the conditions for certification of the batch in question.”
Quarantine stock that is within your control
If warranted you may stop the production unit or packaging line where the mix up / cross contamination has occurred until you can be sure effective CAPAs are in place.
If the investigation indicates it is a true defect and is not something introduced by this customer/user alone then you will submit a defect notification as required by the territory where it is marketed.
The level of market action in the defect notification will depend greatly on the specifics of the medicines involves, the extent of the problem and the patient/user profile. It may require an assessment of how frequently you believe a rogue could be present.
But management point out that the batch you are rejecting is worth a lot of money…. we cant stop production or we will go bankrupt.
This is something that occasionally gets thrown into a scenario. Its important to firmly hold your ground in the face of concerns that are purely economic. Patients first.
Final thoughts?
As with all scenarios this changes radically for different product types and patient populations. You can rehearse with each of the sub variations outlined above - what would need to be the circumstances for you to release the remaining stock? What might make you start a class 1 recall of everything impacted?
Examining all potential “flavours” of a single starting scenarios like this when you have time to reflect on your approach lets you establish and exercise your thinking.
Disclaimer
This document is not a legal document not should it be interpreted in any fashion as a guide. This is a set of notes compiled as part of a personal training program. It is not complete or authoritative. I hope it gives you some value.
This is a personal effort and is not affiliated with my current role or employer.
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. If you use it to train someone else, fantastic, but give the QP Notebook a plug. Thanks