In 2008, ICH Q10 identified Knowledge Management (KM) and Quality Risk Management (QRM) as the enablers of an effective Pharmaceutical Quality System (PQS). Since then, the pharmaceutical industry has been slow in implementing KM, thus missing the quality, operational, and employee engagement advantages KM practices have to offer.
The ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how KM can enable a more effective PQS. The first such guidance in the pharmaceutical industry, the Guide promotes uniting KM with QRM to enable better risk-based decisions. It shows how KM can enhance nearly every element of the PQS across the product lifecycle.
This Guide was written and reviewed by a group of experts in the field, making it a must-have reference to improve your capabilities in managing knowledge and using that knowledge to support an effective PQS resulting in improved PQS outcomes (e.g., better risk-based decision making). Beyond the quality system, substantial and compelling benefits of effective KM include improved business performance by increasing efficiency, building more robust processes, facilitating continual improvement and creating an engaged knowledge workforce.