Regulatory Inspections
What this domain tests
Inspection questions test the inspector’s legal authority, the inspection process, classification of findings and the corrective-action pathway.
Core rules and concepts
- PPB inspectors may enter licensed premises, examine stocks and records, take samples and interview staff.
- Inspections may be scheduled or unannounced. Risk, complaints and previous findings influence frequency.
- Findings range from critical (immediate risk to patients) to major and minor. Critical findings can trigger suspension or closure.
- The inspected entity should provide a root-cause analysis and a corrective and preventive action (CAPA) plan with timelines.
- Follow-up verifies closure. Enforcement may include warning, licence conditions, suspension, seizure or prosecution.
Worked example
An inspector finds expired medicines on the dispensing shelf and no fridge temperature records. Reasoning: expired stock on the active shelf is a critical patient-safety finding; missing temperature records is at least major because cold-chain integrity cannot be demonstrated. The response should segregate the stock, trace affected batches, correct storage, retrain staff, and submit a CAPA with monitoring. Merely discarding the expired items without system correction is inadequate.
Traps that cost marks
Arguing with the inspector instead of documenting corrective action. Treating all findings as equal. Submitting a CAPA without root cause or verification. Assuming unannounced inspections are unlawful. Ignoring record-retention requirements.