Since its creation the API-surveillance programme, performed under the hospices of the API-working group, focused a lot on the authenticity of APIs and the detection of falsified or substandard ones, due to the risks related to the quality of the finished product. With this vision the fingerprint programme was created, where next to conformity analysis to Ph. Eur. Monographs, other types of analysis were performed in order to obtain data, allowing to distinct the different API samples according to their origin or manufacturer. The idea was to obtain a “fingerprint” of the different manufacturer, allowing authenticity checks of suspicious API samples in the future.
After feedback from the network and discussions within the API-Working group, it was decided to change the focus of the API-surveillance programme to quality surveillance and detection of potential quality issues. Therefore the future approach would combine conformity analysis to the Ph. Eur. Monographs with fingerprint studies. Though the latter would be focused on deviating samples and manufacturers, where an inconsistent batch reproducibility could be observed. Pattern recognition techniques would be applied first to group the different manufacturers and select those producers for which deviating samples or inconsistencies are observed. In a second step, pattern recognition techniques for only the samples of the selected manufacturers will be performed to conduct an in depth investigation. The working group identified two approaches for the future MSSFP studies: the first is the parallel approach, where conformity analysis and fingerprint study are performed in parallel and the second is the two-step approach, where the results of the conformity analysis, could trigger the launch of a fingerprint study. The parallel approach is the first choice for the members of the API-working group, due to its advantages in the sampling phase and its flexibility.
The API-surveillance position paper PA/PH/OMCL (12) 51 was revised to reflect the new approach and strategy. The changes were presented for discussion together with some examples of results of the past MSSFP studies, supporting the new approach.
