ISPE Publishes ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

21 May, 2021

Good Practice Guide: Knowledge Management in the Pharmaceutical IndustryISPE announced the release of its latest Guide, ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. The Guide focuses on how Knowledge Management (KM) can enable a more effective Pharmaceutical Quality System (PQS).

The first such guidance in the pharmaceutical industry, the Guide promotes uniting KM with Quality Risk Management (QRM) to enable better risk-based decisions. It shows how KM can enhance nearly every element of the PQS across the product lifecycle.

Knowledge Management focuses on how organizations create, manage, and use knowledge throughout the lifecycle of a product. It, along with QRM, is one of the two enablers of an effective Pharmaceutical Quality System as defined by ICH Q10. Employing KM methods and tools enables organizations to better manage their knowledge as a key asset, in turn improving the effectiveness of the pharmaceutical quality system, providing operational benefits and more.

Co-Team Lead

There are currently few resources, and no industry guidance available which address the role of Knowledge Management specifically for the pharmaceutical industry. This guide works to demystify KM and provides practical guidance, templates, case studies, and references to related ISPE industry guidance to help organizations better understand what KM is, the benefits of effective KM, and how to deploy KM

Associate Director, Knowledge Management
MSD Ireland (Biologics) Ltd
Co-Team Lead

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.

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Guide Team

Paige E. Kane, PhD, CPIP
Director Knowledge Management
Team Lead
Melanie J. Adams
Associate Director, Knowledge Management
MSD Ireland (Biologics) Ltd
Team Lead
Placeholder Person Graphic
Patrick Daniel Blacha
Senior Advisor Tech Services
Eli Lilly & Co
Nuala F. Calnan, PhD
Biopharm Excel Ltd
Stephanie A. Friedrichsen
Associate Director - CCI Coach
Eli Lilly & Co
Anne Greene, PhD
TU Dublin
Frank Hallinan
Senior Director of Quality
Quality System Support (QSS)
Narendira Kumar
Associate Director and Site Quality Head
Dr. Reddy's Lab
Marty Lipa
Executive Director- Knowledge Management