GMP and GDP Inspections in Switzerland
Short answer
Inspections check whether an operation complies with Good Manufacturing Practice or Good Distribution Practice. Swissmedic and the regional inspectorates are responsible. Findings are classed as critical, major or other; corrective action must be evidenced within set deadlines.
Who inspects in Switzerland?
Swissmedic grants the licences and inspects certain areas itself, such as blood products, transplant products and operations with particular risk. For many operations, the regional inspectorates inspect on Swissmedic's behalf. The licence and the certificate always come from Swissmedic.
| Inspection type | Trigger | Lead time |
|---|---|---|
| Initial inspection | New licence application | date agreed |
| Routine inspection | Periodic, risk-based | several weeks |
| Follow-up inspection | Serious findings from the previous inspection | short |
| For-cause inspection | Quality defect, report, suspicion | short notice or unannounced |
| Inspection on request | Certificate for export | date agreed |
| Inspection abroad | Third-country manufacturer without a recognised inspection | long lead time |
How does an inspection proceed?
After the announcement with a list of topics comes the opening meeting, then the walkthrough with document review and interviews, then the closing meeting with the verbal report of findings. The written report follows within a few weeks and requires a plan of corrective and preventive actions.
- Receive the announcement and topic list, prepare contact people and rooms.
- Opening meeting: introduction to the operation, changes since the last inspection, inspection plan.
- Walkthrough and document review, interviews with specialists at their workplace.
- Closing meeting with a verbal report of findings and their classification.
- Written report, followed by a response with an action plan and deadlines.
- Evidence of implementation; a follow-up inspection for critical findings.
How are findings classified?
Critical findings mean an immediate risk to patients and lead to immediate measures up to suspension. Major findings show a system failure with no immediate risk. Other findings are isolated deviations. The classification determines the deadline and the consequences.
| Class | Meaning | Typical deadline | Consequence |
|---|---|---|---|
| Critical | Immediate risk or fraud | immediate | Suspension, recall, follow-up inspection |
| Major | System failure with no acute risk | 30 days for the plan | Follow-up inspection possible |
| Other | Isolated deviation | 60 to 90 days | Evidence in the next cycle |
How do you prepare sensibly?
Effective preparation is operational, not cosmetic: a completed self-inspection cycle, a current Product Quality Review, closed deviations with root cause analysis, and a team that can explain its processes at its own workplace. Tidy folders without a system that is actually lived stand out.
- Site Master File current, with all changes since the last inspection.
- Self-inspections carried out, findings closed with actions.
- Deviations and complaints closed with documented root cause analysis.
- Qualification and calibration status with no overdue items.
- Training records complete per person and activity.
- Recall process tested, contact lists current.
- Data integrity: audit trails are actually reviewed periodically.
Frequently asked questions
Are inspections announced?
Routine and initial inspections, yes, usually several weeks in advance with a topic list. For-cause inspections can happen at short notice or unannounced.
What happens with a critical finding?
Swissmedic can suspend activities, block batches, order a recall and restrict the licence. The measures take effect immediately, independent of the later report.
Are foreign inspections recognised?
GMP inspections from the EEA are recognised under the Mutual Recognition Agreement. For third countries this applies only where corresponding agreements exist or via PIC/S trust mechanisms.
How often do routine inspections take place?
Risk-based, every two to five years. Sterile manufacturing, biological medicinal products and operations with a history of findings are inspected more often than pure wholesale warehouses.
Can I dispute findings?
Yes, as part of the response to the report. This is only worthwhile with evidence; a bare dispute without proof extends the procedure and raises attention at the follow-up inspection.
Sources
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