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.
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?
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:
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.
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.
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 really critical cases remain.
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.
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?
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.
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.
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.
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.
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.
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.
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.
Questions about FMD or Lean FMD? Just call or text us.