Quality risk management updated to ICH Q9(R1)
Ergopharm has updated its quality risk management procedures to ICH Q9(R1), the revised guideline adopted at Step 4 in January 2023.
The revision addresses weaknesses the industry had lived with for fifteen years: the subjectivity that creeps into risk scoring, the tendency to apply the same heavyweight process to trivial and critical questions alike, and the need to connect risk management to product availability as well as to product quality.
“A risk score without its reasoning is a number somebody made up.”
In practice the site's procedures now state explicitly what level of formality a given question warrants, and require that the basis of a probability or severity judgement be recorded rather than merely scored. Where data exist, they are used; where they do not, the assumption is written down as an assumption.
The framework continues to govern validation scope, sampling design, change evaluation and the depth of deviation investigation.
Key facts
- Guideline
- ICH Q9(R1), Step 4, January 2023
- Addresses
- Subjectivity, formality, product availability
- Now required
- Basis of each judgement recorded, not only scored
- Governs
- Validation, sampling, change, investigation depth
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.