The Journal of Validation Technology
Vol. 21, Issue 4, Dec 2015

Kelly Waldron
Kevin O’Donnell
This special issue consists of eleven papers, each exploring a different topic and perspective within the QRM space. These papers reflect on how far industry has come since the inception of ICH Q9 in June 2005, as well as provide tangible solutions to improve the effectiveness of QRM so that it continues to deliver value to the patient.
Kevin O’Donnell
The past ten years since the finalisation of ICH Q9 have seen significant efforts by industry and regulators to increase use of risk-based approaches in pharmaceutical applications. The GMPs, in particular, have undergone very significant changes to reflect the concepts of QRM, both in the US and EU. Despite these efforts, the question remains...
Anne Greene
Nuala Calnan, Ph.D.
The publication of the ICH Q9 Quality Risk Management (QRM) guideline in 2005 has greatly impacted the pharmaceutical sector. Q9 established the clear priority for patient protection through the effective evaluation and management of associated risks. This paper asks whether the integration of efforts by the industry, its associations, and...
Ghada Haddad
Lorianne Richter
Senior leadership has a significant role in ensuring the success of Quality Risk Management in the organization. Company leaders must invest in, and be accountable for, risk management programs. Their objective should be to proactively manage risk – prevent risk rather than only correcting risk situations. Senior leaders have distinct...
David L. Chesney
Major global health regulatory authorities now emphasize Quality Risk Management (QRM) as an important process to assure drug quality and safety. Despite the ICH Q9 guidance, recurring inspection observations, and ongoing educational activities, companies struggle to conduct effective risk assessments. This paper highlights five of the more...
Amanda Bishop McFarland
Kelly Waldron
etectability is often defined as the ability to detect a failure before it causes harm. The purpose of considering detection in any scenario is to ensure that potential or actual failures can be identified with enough time to take action before the user is adversely affected. Risk assessment tools may (i.e., FMEA) or may not (i.e., HACCP)...
Emma Ramnarine
This paper explores ways in which subjectivity and uncertainty can impact decision-making even when QRM is applied, and it presents ways to facilitate awareness of bias and manage it. Several types of cognitive biases such as anchoring bias, status quo bias, and knowledge bias that have implications in the application of QRM are described....
Gregg Claycamp
The internationally-harmonized guideline “ICH Q9 Quality Risk Management” has been in use for a decade. Perhaps due partly to publication of the guideline, there is as growing use of quality risk management methods or “tools.” This perspective discusses the types of concerns about subjectivity and why quality risk management tools “can go wrong.”
Richard L. Friedman
A pharmaceutical manufacturer is responsible for implementing robust daily operations that consistently yield good quality drugs. This paper discusses how a mature quality system assures a state of control throughout the product lifecycle by vigilantly managing manufacturing and quality risks.
James Vesper
This paper addresses risk communication, its purpose from a Q9 point of view, and ways that risk communication can be improved and contribute to better decisions and actions. Risk communication and its purpose are defined in ICH Q9. Despite the simplicity of concepts, risk communication has proven to be difficult. Categories of problems in the...
Aidan Harrington
This paper describes an application of QRM principles to a C&Q case study and an assessment of the benefits of the approach. The case study describes the implementation of isolator technology in an aseptic filling system. This technology requires controls for critical aspects of the system. The lifecycle for identification of system...
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