By Andy O’Connor, ERA Sciences
Published in: Pharmaceutical ONLINE
Published on: April 16, 2025
In the highly regulated world of pharmaceuticals and life sciences, risk isn’t just a numerical score — it’s a story of what might happen. Regulatory frameworks like ICH Q9 and ISO 31000 anchor our approaches to quality risk management (QRM), but even with all this guidance, a silent disruptor often creeps in: subjectivity.
Subjectivity is both a threat and an opportunity. If unchecked, it clouds judgement, introduces bias, and can lead to decisions that fail to prevent harm to patients. But when understood and managed properly, subjectivity becomes a source of creativity, revealing hidden hazards and unlocking more effective risk controls. The delicate balance of subjectivity management has been acknowledged in the recent FDA and ICH Q9 R1 updates, which bring subjectivity into the spotlight as a factor that can undermine the effectiveness of QRM if not properly addressed.
