ISPE Releases New Knowledge Management Guide

BioPharm International Editors

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

The International Society for Pharmaceutical Engineering (ISPE) announced on May 21, 2021 that it has released its latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry, which focuses on how knowledge management (KM) allows for a more effective pharmaceutical quality system (PQS).

Written and reviewed by experts in the field, the guide works to show how KM can improve elements of the PQS across the product lifecycle, while providing tools to improve management knowledge capabilities and risk-based decisions, ISPE said in a company press release.

“Knowledge Management focuses on how organizations create, manage, and use knowledge throughout the lifecycle of a product. It, along with [quality risk management], is one of the two enablers of an effective pharmaceutical quality system as defined by ICH Q10,” said Paige Kane, guide team co-lead, director Knowledge Management, Merck & Co, in the press release. “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.”

"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,” added Melanie Byrne, guide team co-lead, Knowledge Management lead, Pfizer, in the press release.

Source: ISPE