- Cultivation (GACP Site)
Cannabis cultivation under EU GACP or WHO GACP. Swissmedic accepts both standards. Swiss domestic cultivators operate under fedpol cultivation licenses.
- GACP Controls
Standard GACP controls — identical to EU requirements given Swissmedic/EU GMP alignment.
- Pesticide logs — EU MRL basis
- Variety genetic documentation
- Harvest moisture: ≤10%
- Environmental monitoring
- Manufacturing IPC
Swissmedic GMP is fully EU-GMP aligned (PIC/S member, EU MRA). In-process controls follow EU-GMP standards identically.
- HPLC cannabinoid IPC
- Weight uniformity
- Cleanroom monitoring
- Line clearance records
- Finished Product Testing
Release testing per Swiss Pharmacopoeia (Ph. Helv.) and European Pharmacopoeia (Ph. Eur.) — both valid in Switzerland.
- Identity and assay: THC, CBD profile (HPLC)
- Microbiological: TAMC, TYMC, E. coli, Salmonella
- Pesticide residues (EU MRL)
- Heavy metals per Ph. Eur. 2.4.27
- Moisture (dried flower ≤10%)
- Residual solvents if extract (ICH Q3C)
- All specs pass?
All results must comply with Swissmedic-approved specifications and Ph. Eur./Ph. Helv. limits.
- OOS Investigation
OOS investigation per Swissmedic GMP expectations — identical to EU-GMP ICH Q7 approach.
- Phase 1: lab investigation
- Phase 2: manufacturing investigation
- Notify Swissmedic if released batch affected
- Verantwortliche Person Release
Person responsible for batch release (verantwortliche Person für die Freigabe) certifies the batch per Swissmedic requirements.
- Full batch record reviewed
- All results within specification
- GACP and GMP certificates current
- Signed batch release certificate
- Batch Released ✓
Certified for Swiss supply. Available for distribution to pharmacies across all 26 cantons.