September 2017

For a study to be run under GLP compliant conditions, many supporting quality processes have to be in place.

The QAU provides independent assessment of the robustness of these systems by examining them using audits that analyze how processes are implemented at each step of study execution. The QAU uses these facility and process-based inspections to ensure quality in a systematic, rather than study-by-study manner.

For example, personnel training is examined to ensure that the standard operating procedure is being effectively implemented across the lab, that such training is consistently documented, and that personnel have the appropriate training for tasks in which they’re involved.  Another example is analyzing the lab’s compliance with regards to equipment. Do the lab’s standard operating procedures define how a new piece of equipment is received/retired, how it is to be used, how it is to be calibrated?  Whatever the specific instance may be that the QAU is examining, Microchem’s QAU traces the lab’s quality systems back to the GLP regulations they satisfy to verify they are sufficient and checks that these systems are appropriately implemented in order to ensure the data and conclusions withstand rigorous scientific scrutiny.