R.D. McDowall | Authors

Are your OOS investigations scientifically sound and is the assignable cause correct? Or are OOS results invalidated using the ever-popular justification of analyst error?

The United States Pharmacopeia general chapter on Analytical Instrument Qualification has been updated and became effective 1 August 2017. So, what has changed?

The authors discuss metrics for monitoring data integrity within a chromatography laboratory, from the regulatory requirements to practical implementation.