medAspis Alert Guard – Guidelines for BeMVO
A critical alert occurs and is reported.
Based on the FAMHP note of August 2019, the alerts are currently not an obstacle to delivering or distributing the products. However, pharmaceutical companies must be prepared when FAMHP decides to fully apply the FMD principles, namely that in the case of an alert, the pack must be kept for further investigation.
- When an alert occurs, BeMVO also receives a copy of this alert.
- BeMVO analyses the alert in detail:
- does alert show that the pack was already inactive when scanned?
- is there a problem with the manufacturer (data not uploaded, etc.)? In that case the manufacturer will be contacted immediately.
- Once a day, all processed alerts of the last 24 hours are merged per user and an e-mail is prepared with an overview of the detected alerts. If possible, the alert is classified, the probable cause is described and what can be done to avoid such alerts in the future.
- The pharm. company should not react unless the stated probable cause does not apply or that there may be a further problem with the pack.
In addition, the FAMHP has in March 2022 made known its intention to visit companies for unannounced FMD audits.
Diagram of the process flow
Procedure without medAspis
The area with a grey background is the part of the process chain visible to the pharmaceutical company. However, FAMHP receives data access to every critical alert. Differences between alerts registered at BeMVO and those reported and processed by the company itself can be immediately detected.
Diagram of the process flow with medAspis
medAspis takes a lot of work out of the pharm. operation all the work. Nevertheless, the company is fully GxP-compliant.
