Method Validation by Phase of Development.

The article informs that the validation of analytical methods is an essential but time consuming activity for most analytical development laboratories in the pharmaceutical industry. As such, it is a topic of considerable interest in the literature and at pharmaceutical conferences. The examination of method validation practices is driven by several factors, including the desire to conduct the right science at the right time with optimal resources while maintaining the ability to rapidly implement change during the development process. Although performing validation in phases has clear benefits, it also must be noted that potential risk is associated with this approach. INSET: Purpose of analytical methods by phase of development.