Development and validation of automated methods for finished product testing

The use of automated sample preparation and dissolution methodologies is widespread in the pharmaceutical industry. However, guidance on the development and validation of these methods has been limited. The automation subgroup of the Pharmaceutical Analytical Sciences Group, which represents pharmaceutical companies with UK-based research and development operations, has pooled its expertise to produce a set of detailed guidelines. The hope is that this document, presented in this article, will allow both the novice and expert user to produce high-quality, robust, automated methodologies.