Learn How to Manage Knowledge & Improve PQS Effectiveness
Knowledge Management (KM) is a discipline (akin to Quality Risk Management (QRM) or Lean Six Sigma) that focuses on how organizations create, manage, use, and share knowledge. The publication of ICH Q10 in 2008 saw the formal designation of KM as a key enabler for an effective Pharmaceutical Quality System (PQS), along with QRM. Since then, the industry has acknowledged the importance of managing knowledge across the lifecycle to enhance process understanding, improve decision making, and enable more robust risk management. ICH Q10, and the more recent ICH Q12, discuss the expectations for organizations to proactively manage product and process knowledge citing the potential of more efficient and effective regulatory oversight (e.g. ICH Q12). There are currently few resources, and no industry guidance, available which address the role of Knowledge Management specifically for the pharmaceutical industry.