How Knowledge Management Can Improve Quality and Increase Efficiency
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical industry has made significant progress in adopting QRM into systems and processes. However, the 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 shows how KM can enhance nearly every element of the Pharmaceutical Quality System (PQS) across the product lifecycle and lead to other benefits such as improved business performance by increasing efficiency, building more robust processes, facilitating continual improvement, and creating an engaged knowledge workforce.