In-line & Release Testing

Workflow steps

1. Cultivation (GACP Site)
   Cannabis cultivation under EU GACP or WHO GACP. Dutch domestic cultivators (OMC-contracted Bedrocan) operate under strict GACP-compliant SOPs.
2. GACP Controls
   Full GACP compliance for all cultivation stages.
   • Irrigation and nutrient logs
   • Pesticide records — EU MRL basis
   • Variety genetic identity documentation
   • Environmental monitoring
   • Harvest moisture: ≤10%
3. Manufacturing IPC
   EU-GMP Part I manufacturing with in-process controls. Netherlands applies full EU-GMP — no national deviations.
   • HPLC cannabinoid assay at IPC
   • Weight checks per unit/batch
   • Cleanroom environmental monitoring
   • Line clearance records
4. Finished Product Testing
   Full release panel per EU Pharmacopoeia and OMC/CCBM product specifications.
   • Identity and assay: THC, CBD, terpene profile (HPLC)
   • Microbiological: TAMC, TYMC, E. coli, Salmonella
   • Pesticide residues (EU MRL)
   • Heavy metals: Pb, Cd, Hg, As (Ph. Eur. 2.4.27)
   • Mycotoxins: aflatoxins, ochratoxin A
   • Moisture (dried flower)
   • Residual solvents (extracts)
5. All specs pass?
   All results must comply with approved EU specifications and Ph. Eur. limits.
6. OOS Investigation
   OOS investigation per EU-GMP and IGJ expectations. Root cause analysis mandatory.
   • Phase 1: lab investigation
   • Phase 2: manufacturing investigation
   • Notify IGJ if OOS affects released batch
7. EU QP Batch Release
   EU Qualified Person reviews all documentation and certifies the batch. QP named on Dutch WDA.
   • Full batch record reviewed
   • All deviations closed
   • GACP and GMP certificates current
   • QP signature on batch certificate
8. Batch Released ✓
   QP-certified batch available for wholesale distribution to Dutch pharmacies via licensed distributors.