Compliance in Serialisation

The 2019 Falsified Medicines Directive (FMD) makes it clear: any suspicion of falsification must be addressed, and any falsification must be removed from distribution. In order to meet the strict requirements of the authorities, companies from the pharmaceutical industry must act GxP-compliant at all times. And this concerns every single falsification alarm.

With Lean FMD and active Alert Management, medAspis has developed an advanced service that prevents virtually all false alerts to the authorities and processes the remaining cases according to the rules.

Do you know what to do in the event of a falsification alarm?

Falsification alerts arise in many day-to-day situations: e.g. packs are deactivated twice by mistake or goods are delivered that have already been deactivated. Depending on the scan volume, this can be hundreds of alerts per day. These cases of suspected falsification must be separated and, if necessary, manually checked and documented. That means a lot of work.

In addition, the authorities are always in the loop; they are automatically informed about every mistake and can still make critical enquiries 5 years from now. Do you have the right answers then?

How do critical falsification alarms arise in the first place?

Many everyday situations lead to alerts that may indicate a suspicion of counterfeiting. This happens much more often than you think:

Double deactivation by mistake: The error message in the case of self-inflicted double deactivation ends up directly with the authorities.
Goods already deactivated received from supplier: Call the supplier and the goods will be returned. But the authorities are aware.
Unknown 2D matrix code: The code on the pill box is not recognised. Not uploaded by the manufacturer or falsification? A case for the authorities.

Why do these cases jeopardise compliance?

A falsification alert indicates that a counterfeit medicine has been found or a possible falsification is present. Every single suspected case must be investigated. In terms of quality assurance and compliance, the following two cases are particularly important:

Counterfeiters could print random serial numbers on packs. Alerts of this type can only be resolved with the support of the manufacturer.

Counterfeiters could print genuine serial numbers from old packs onto new packs. So packs that have already been deactivated carry a risk of counterfeiting.

Risky: insufficient compliance

FMD scans are part of everyday work in pharmaceutical distribution. But so far, hardly any precautions are taken to reduce the numerous counterfeit alarms. Truly critical cases often get lost in the mass and are consequently not handled correctly.

Every single case is automatically reported to the authorities and debits your compliance account. Sooner or later, audits will take place – and the authorities will demand accountability for individual scans.

In principle, medicine packages suspected of being counterfeit must be separated. Because the next scan at your customer’s definitely leads to the same alert. The pack comes back and causes even more trouble.

Lean FMD: keeping things running smoothly

medAspis has the entire FMD process perfectly under control. That’s why we enable not only extremely fast and efficient, but also virtually error-free processing.

With Lean FMD, virtually no more alert messages

The reason for the vast majority of false alarms is accidental multiple deactivations. medAspis Lean FMD identifies these and prevents almost all triggered false alarms. Our double scan filter reduces the number of alert messages to the NVMS that could trigger regulatory investigations to almost zero. Only the truly critical cases remain.

For the worst case: so that everyone knows what to do

You can rely 100% on medAspis if an alert does occur. We provide all participants with exactly the information they need in their position. Clear, well structured, quality-assuring and productivity-promoting.

Precise guidance for the scanning staff

Instant scan stop in case of critical alerts. Our poster with clear handling instructions shows your employees: Is the alert critical? And what to do now?

Detailed information for supervisors

medAspis provides supervisors with simple but precise explanations of all critical alerts: What are the next steps? What decision needs to be made now? What do the scanning staff need to know? All background information is easily accessible in our system.

Complete documentation for the responsible person

The pharmaceutically responsible person and the quality managers receive all documents from medAspis in order to align SOPs and work instructions in the quality manual exactly according to NVMS and officially required procedures.

medAspis Alert Management: our Zero Alert Programme

Despite all the training and well-intentioned advice, we know from experience that the scanning staff cannot always be relied upon and that suspected counterfeits are often lost in the day-to-day operations.

Handle critical cases professionally

Our active alert management ensures that no counterfeit alert is overlooked. The suspected cases are clearly presented, and there are exact instructions for action for each individual case. Each case is clearly documented.

Continuous Improvements

In order to systematically exclude more and more alert cases in the future, we are monitoring the findings of our alert team very closely. On this basis, we can help to optimise work processes and eliminate further sources of alerts in close consultation with you.

active Alert Management

Assistance with all difficult cases: With our active Alert Management Programme, the medAspis Alert Guard Team is at your side with competence, experience and solution orientation.

Lean FMD & active alert management:
Compliance benefits at a glance

Less risk: Lean FMD is the best solution to meet your compliance and quality assurance requirements.
Lean FMD can be fully integrated into your workflows.
Lean FMD reduces costs and staff time for handling suspicious cases.
Careless errors during scanning are effectively prevented.
FMD false alarms to authorities are reduced to almost zero.
During audits, all questions from the authorities can be comprehensively clarified. Every scan and every alert handling is documented.
Concentrate fully on your core business – and don’t waste your valuable time on the side show FMD.
With Lean FMD, you can sustainably optimise your FMD processes.

medAspis: Your 360° FMD Partner

With efficient scanning, a reduction of false alarms to almost zero and takeover of critical cases, medAspis is your 360° partner for FMD. With our service you reduce the amount of false alarms to the authorities to almost zero. We take care of all the rest. With Lean FMD, you can be sure that you are taking the best possible compliance and quality assurance measures at this moment.