Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the...

Area of Science:

• Pharmaceutical Regulatory Science
• Knowledge Management
• Technology Transfer

Background:

• ICH Q10 identifies Knowledge Management (KM) as a key enabler for Pharmaceutical Quality Systems (PQS).
• Despite its introduction over a decade ago, KM maturity in the biopharmaceutical sector remains a challenge.
• Ineffective KM may limit the full benefits of ICH Q8, Q11, and Q12 guidelines.

Purpose of the Study:

• To explore practical solutions for improving knowledge management across the pharmaceutical product lifecycle.
• To focus on enhancing knowledge transfer specifically within technology transfer projects.
• To address challenges hindering effective knowledge flow in pharmaceutical development and manufacturing.

Main Methods:

• Identification of challenges associated with ineffective knowledge transfer.
• Determination of high-level requirements for effective knowledge management.
• Development of a four-step framework and accompanying KM toolkit for enhancing knowledge transfer.

Main Results:

• A systematic four-step framework was developed to enhance knowledge transfer.
• A KM toolkit comprising tools, processes, and behaviors was created to facilitate knowledge flow.
• The framework's applicability was demonstrated across the entire pharmaceutical product lifecycle.

Conclusions:

• The developed framework and toolkit offer practical solutions to improve KM in the biopharmaceutical sector.
• Effective KM is essential for realizing the full potential of pharmaceutical quality and lifecycle management guidelines.
• This research supports the evolution of KM from an enabler (ICH Q10) to a key consideration (ICH Q12).