ISPE Issues Change-Management Guide

Article

New guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.

The International Society for Pharmaceutical Engineering (ISPE) has released the latest volume in the Product Quality Lifecycle Implementation (PQLI) series, Change Management System as a Key Element of a Pharmaceutical Quality System. The guide, which is Part 3 of the PQLI series, provides practical, real-world strategies that companies can use to implement the change-management recommendations of ICH Q10.

The PQLI guide on change management outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system (PQS). It provides guidance on achieving compliant and consistent change-management systems and describes how to implement compliant change-management systems within a PQS. PQLI 3–Change Management can be used in conjunction with the first two PQLI guides as part of a larger quality-by-design approach or as a stand-alone change-management manual.

Recent Videos
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Industry Outlook 2025: The Rising Prominence of AI in Pharma
Leroy Hood, MD, PhD
Adam Sherlock, CEO of Qinecsa, discusses the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.
Related Content