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

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 gives an indication of the quality of the product on some distinct parameters, often chosen based on the manufacturing process. A MSSFP study allows to obtain a global image of the sample, to compare to the batches of the (presumed) manufacturer and/or to the data of fingerpint studies performed in the past in order to detect falsifications.

In the presentation the new concept of the combined CAP/MSS/MSSFP studies is presented as well as a summary of the first MSSFP study of this kind on sildenafil citrate (MSSFP004) and this for both the set-up of the study as the obtained results, the conclusion and the lessons learned.

Further the ongoing MSSFP005 study on tadalafil is introduced and some future perspectives for API-fingerprint studies within the OMCL network are discussed.