How to ensure the safety of pharmaceuticals?
Impurities in drug products
Pharmaceutical manufacturers use materials from a variety of suppliers to compose the final medicinal product for the market. Patient safety is of utmost necessity for these medicinal products. This is ensured by a network of guidelines summarized under the term GMP – good manufacturing practice. Under these GMP guidelines the responsibility for the control of all components of a drug product is described thoroughly. In other, more technical documents (e.g. pharmacopeias and specifications) the required analytical testing is described in detail.
Even if all these regulations and guidelines are strictly followed, sometimes unexpected impurities are detected in long marketed drug products. This leads to uncertainty for the consumers and in the worst case to health risks for the patients.
The best way to avoid such a scenario is to have a very deep scientific understanding of the chemistry of all components used in a drug product. This is valid for rather simple drug products that are already used for a long time as well as the newest biopharmaceutical products that are currently entering the market.
Analytical Support
Tentamus Group is a service provider for analytical services for the pharmaceutical industry that is able to support companies in the physio-chemical analysis of their raw materials as well as their final products. Following an integrated approach of risk analysis, method development to a final qualified and validated method, Tentamus is already the preferred partner for many pharmaceutical companies.
Impurity analyses, such as for example N-Nitrosodimethylamine and other nitrosamines that have been in the news already twice and more importantly impurity prevention, by using orthogonal method application, is one of the strengths of the Tentamus labs. We encourage you to get in contact with us and test our capabilities.
Contact:
Gerald Hofer
gerald.hofer@tentamus.com
+43 699 131 431 60