Regulatory Inspections
Regulatory inspections test how PPB verifies compliance with licensing, GMP, GDP, dispensing and clinical-trial requirements, and how a facility responds to findings.
Inspection types and powers
PPB conducts routine, pre-licensing, targeted, complaint-driven, GMP, GDP and clinical-trial site inspections. Inspectors may enter premises, examine records, take samples, photograph conditions, interview staff and require explanations. Findings are graded by risk - often critical, major, minor or observation - and the facility must submit a corrective and preventive action (CAPA) plan with root-cause analysis, responsible persons and timelines. Serious findings can lead to reinspection, suspension, seizure, warning or prosecution. Cooperation and accurate records are part of compliance.
Worked example
An inspector finds a three-day gap in the cold-room temperature log. Because there is no evidence that vaccines were kept within range, the finding is major rather than a trivial paperwork issue. The CAPA should identify the root cause (for example, staff omission), install continuous monitoring with alarms, revise the SOP, train staff, assess the affected stock retrospectively, and set a verification date. A generic “staff will be careful” response is inadequate because it does not address root cause or prevent recurrence.
Traps that cost marks
- Hiding or altering records during an inspection.
- Submitting a CAPA with no root-cause analysis.
- Missing CAPA deadlines or failing to verify effectiveness.
- Treating an inspection as an internal audit with no regulatory consequence.
- Not training staff on the revised SOP after a finding.
- Ignoring cold-chain or storage evidence gaps.