GMP Services
Quality Management System solutions
Design, implement and strengthen a pharmaceutical quality system that meets regulatory expectations and works for the people who run it.
Learn moreGMP Services
Quality Risk Management
Practical quality risk management that identifies, assesses and controls risks to product quality and patient safety.
Regulators expect risk-based decision making across the product lifecycle. We help teams apply ICH Q9 principles proportionately: enough rigour to defend the decision, without turning every assessment into a lengthy exercise.
Typical scope
- Risk-management procedure and tool selection (FMEA, HACCP, preliminary hazard analysis and others)
- Facilitated risk assessments for processes, facilities, equipment and suppliers
- Linking risk outcomes to validation scope, change control and CAPA
- Training for assessment leads and participants
How we approach it
Proportionate
The depth of analysis matches the risk, in line with ICH Q9.
Decision-focused
Assessments end with controls, owners and verification, not just a score.
Integrated
Risk outputs feed validation, change control and CAPA rather than sitting apart from them.
Related services
GMP Services
On-site training, including new hires
Role-specific GMP training delivered at your facility, with induction programmes for new starters.
Learn more