ISPE Guide: Quality Risk Management

Published: May 2026
Pages: 196

• Table of Contents
• Special Pricing for Emerging Economies

The ISPE Quality Risk Management (QRM) Guide provides comprehensive, practical guidance for applying Quality Risk Management throughout the pharmaceutical and combination product lifecycle in alignment with ICH Q9(R1). As regulatory expectations and supply challenges continue to evolve, this Guide supports organizations in strengthening science based and risk-based decision making while improving product quality, patient safety, and supply reliability.

The ISPE QRM Guide is designed to help organizations:

• Apply the principles of ICH Q9(R1) consistently and effectively across development, technology transfer, commercial manufacturing, and post approval lifecycle management
• Reduce subjectivity in risk assessments by leveraging structured approaches, appropriate tools, facilitators, evidence, and knowledge management
• Determine and apply the right level of formality, proportionate to risk, uncertainty, and complexity, thereby improving decision quality and resource efficiency
• Strengthen risk-based decision making (RBDM) at both operational and leadership levels
• Integrate QRM with the Pharmaceutical Quality System (PQS) to support a state of control and continual improvement
• Address product availability and supply resiliency risks, recognizing that patient harm may arise not only from quality defects but also from loss of access to medicines

Covering the full product lifecycle, the Guide integrates regulatory expectations, ISO standards, knowledge management principles, and operational excellence practices. With real-world examples, decision frameworks, and case studies, this Guide will help organizations strengthen their Pharmaceutical Quality Systems, improve supply resiliency, and deliver safe, reliable medicines to patients.

Guide Core Team

Alice Redmond, PhD

Chief Strategy Officer

CAI

Magalie Blackie

Head of Haleon Global Quality Services

Haleon

Caroline Cuel

Senior Advisor, Quality & Compliance

F. Hoffmann-La Roche Ltd

Jean François Duliere

Regulatory Advisor

ISPE

Jessica Hale

Associate Director-US & Global Regulatory Affairs

Merck & Co Inc

Diane Hustead

Executive Director, Regulatory Affairs

Merck & Co., Inc.

Margaret M. Leahey

Director - International CMC EU/EEU/ME/A

MSD - Dublin

Martin Lipa

Executive Director, KM/QRM

PRST

Christine Moore

Executive Director, Quality Systems & Compliance

Organon LLC

Rosemary Orciari

Director Quality Operations

Pfizer, Inc.

Maurice Parlane

Principal/Director

New Wayz Consulting Ltd/CBE Pty Ltd

Christopher Potter, PhD

ISPE CMC Pharmaceutical Consultant

Chris Potter Consulting Ltd

Lisa Robertson

For the full list of contributors to this Guide see Guidance Document Teams