Safe and stable – the importance of stability data
The presentation of clinical trial supplies can play a crucial role in creating a professional image, influencing subject compliance and ensuring the quality of the investigational product. Barry Mansfield looks at how the existence of stability data is often the deciding factor when selecting a particular type of packaging.
In pharmaceutical packaging, stability data can be used to guide the manufacturer in its decisions as to how the final product should be presented or stored. Long-term stability studies involve myriad sophisticated techniques depending on the special criteria relating to the specific drug and necessary storage conditions. These should meet International Conference on Harmonisation (ICH) guidelines for drug development, but third-party specialists often include follow-up stability studies for all ICH-standard storage conditions, as well as low-temperature storage (-20°C), special temperatures, relative humidity or container orientation.
Source: World Pharma