- Cultivation (GACP Site)
Cannabis cultivated at IMFA-licensed cultivation site. GACP compliance is mandatory. IMFA conducts periodic unannounced inspections of cultivation sites.
- GACP Controls
Cultivation under EU GACP or WHO GACP standard. IMFA requires ISO 17065-accredited third-party certification.
- Irrigation, fertilisation, pesticide logs
- EU MRL pesticide limits apply
- Variety and genetic identity documentation
- Environmental monitoring records
- Manufacturing IPC
GMP manufacturing with in-process controls. Israeli export-oriented manufacturers typically hold EU-GMP Part I — IPC standards are EU-GMP aligned.
- HPLC cannabinoid content checks during processing
- Weight uniformity per batch
- Environmental monitoring per GMP grade
- Line clearance records
- Finished Product Testing
Full release panel per IMFA requirements and destination country specifications. Export batches typically tested to EU Pharmacopoeia standards.
- Identity and assay: THC, CBD, cannabinoid profile (HPLC)
- Microbiological: TAMC, TYMC, E. coli, Salmonella
- Pesticide residues (EU MRL basis for EU export)
- Heavy metals: Pb, Cd, Hg, As
- Mycotoxins: aflatoxins, ochratoxin A
- Moisture (dried flower ≤10%)
- Residual solvents if extract
- All specs pass?
All results must comply with IMFA-approved product specifications and destination country standards.
- OOS Investigation
OOS investigation per IMFA GMP requirements and ICH Q7. Root cause analysis mandatory before any retest or batch disposition decision.
- Phase 1: lab investigation
- Phase 2: manufacturing investigation if needed
- Notify IMFA if OOS impacts a released batch
- QP / IMFA Release
Qualified Person (for EU-GMP sites) or IMFA-designated batch release person reviews all documentation and certifies the batch.
- Full batch record reviewed
- All IPC and finished product results within spec
- GACP and GMP certificates current
- Export: destination country specs verified
- Batch Released ✓
Batch certified. For domestic: available to Israeli dispensaries. For export: IMFA export permit application can proceed with QP-certified COA.