Subsequently to the issue of the Final Guidance on Recommended Acceptable Intake Limits for Nitrosamines, recently released by FDA, EMA, and Health Canada, Olon, a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and general markets, publishes the white paper “Olon case, Management of nitrosamine standards.” The white paper exposes the status and Olon’s 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 patient health and with reference to the recent authorities' notifications, Olon in 2019 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 of R&D, QA, Regulatory Affairs, and QC both at site and corporate levels. For the aspect related to the manufacturing process, it is useful that many of the steps are made in GMP at Olon sites (sometimes even the starting material itself is made in-house). Therefore, there is prompt control of all the materials used, coming from validated suppliers, and the information is easily available.
This is a new, sudden challenge from the authorities, to which Olon is responding quickly and thoroughly, in the spirit of collaboration with suppliers, customers, and the authorities themselves. It is at the forefront of 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.
To see the full white paper link HERE
