Preparing for your First MHRA Inspection
A first MHRA inspection is not simply a document review. Inspectors are assessing whether the organisation understands its processes, controls its risks and can demonstrate effective quality governance.
What inspectors are assessing
- Whether staff understand the process and the rationale for controls.
- Whether deviations, changes and CAPAs are investigated and governed effectively.
- Whether data trails support the story being presented.
- Whether senior leadership has appropriate oversight of quality risk.
Common weaknesses
- Weak investigation rationale.
- Training records that do not demonstrate effectiveness.
- Validation decisions without clear scientific justification.
- Incomplete management oversight of recurring risks.
Practical preparation
Effective preparation should include mock interviews, critical system walkthroughs, data trail checks and challenge of assumptions before the inspection starts.
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