The white paper exposes the status and Olon response to potential contamination of pharmaceutical products by the genotoxic impurities known as nitrosamines.
Since the presence of nitrosamines may be associated with health risks, taking into consideration the primary importance of the patient health and with reference to the recent Authorities notifications, Olon in 2019 timely issued a nitrosamine policy, applied by all Olon manufacturing plants, and started a systematic review of the potential presence of nitrosamines in all its active pharmaceutical ingredients (APIs), about 300 APIs.
The revision involved a multidisciplinary team composed by R&D, QA, Regulatory Affairs, QC both at Site and Corporate level. For the aspect related to manufacturing process, it is useful that many of the steps are made in GMP in Olon sites (sometimes even the starting material itself is made in-house). Therefore, there is a prompt control of all the materials used, coming from validated suppliers, and the information are easily available.
This is a new sudden challenge that came from the authorities, in which Olon is responding quickly and thoroughly, in the spirit of collaboration with suppliers, customers and authorities themselves. It is at the forefront in dealing with the regulatory requirements for risk assessment and analysis of nitrosamines as evidenced by the results obtained in terms of timing and quality of the analyzed APIs, which largely comply with the highest safety standards determined by the EMA, FDA and Health Authorities.
As a virtuous adjustment for nitrosamine control, it is highlighted how the Mahad site has successfully implemented the air-free process for the manufacture of Rifampicin.