OMCL testing and the API working group: Part of the solution?

Last updated on 6-9-2022 by Eric Deconinck

Scientific poster, presentation or proceeding





Within the OMCL network different initiatives were taken to augment the analysis and market surveillance of APIs used by different manufacturers. Despite the efforts, API testing within the network is limited, compared to the surveillance of finished products. Though it has to be said that the risk for quality deficiencies and falsification of APIs is real and was shown by several crisis. Therefore the API-WG organizes atypical market surveillance studies (MSS), where an MSS (analysis according to the Ph. Eur.) is combined with a fingerprint study (MSSFP). An MSS, according to Ph. Eur. only…

Associated health topics:

QR code

QR code for this page URL