Stability studies are ever changing: Outsourcing as a viable option
Drug stability testing is one of the most important parts of the drug production process. These tests aim to determine the performance of a drug under different conditions, such as humidity, sunlight and temperature, and therefore help to decide safe expiry dates.
The difficulty is that the specific stability data required by authorities in each market differs. As a result, testing programmes have to be developed with the specific market in mind.
In addition to this, the information gathered can help firms forecast demand and plan out logistics, however as different regulatory authorities have different testing rules, this can be difficult for companies that supply to multiple countries.
In an article published in Manufacturing Chemist, Ramesh Jagadeesan, Senior Director Analytical Development at Recipharm, discusses emerging trends in stability testing and explains how working with the correct services partner can streamline and accelerate the process.
For the full article see: https://content.yudu.com/web/fiqy/0A3zgsi/manufactchemistoct18/html/index.html?page=54&origin=reader in Manufacturing Chemist.