- Cultivation (GACP Site)
Cannabis cultivation under GACP-certified conditions. Variety selection, cultivation parameters, and IPM documented per GACP standard.
- GACP In-Process Controls
Ongoing monitoring during cultivation: irrigation, pesticide records, growth stage documentation, environmental monitoring.
- Irrigation and fertilization logs
- Pesticide application records (EU MRL basis)
- Weekly growth stage documentation
- Temperature, humidity, and light logs
- Harvest & Post-Harvest
Controlled harvest, drying, and trimming under GACP. Moisture content, visual inspection, and initial cannabinoid profiling.
- Target moisture: ≤10% (dried flower)
- Visual: absence of mold, pests, foreign matter
- Initial cannabinoid profile by HPLC
- Transfer to GMP Site
Bulk material transferred to EU-GMP certified manufacturing site with full chain of custody documentation.
- GACP chain of custody transfer document
- Batch traceability record
- Material identity confirmed on receipt
- GMP Receipt Testing
Upon receipt at GMP site: identity, appearance, and contamination screening before materials enter manufacturing area.
- Identity by HPLC or NIR
- Appearance and foreign matter check
- Pesticide and heavy metal screening
- Microbiological limit test
- Manufacturing & IPC
Processing steps (grinding, extraction, filling, packaging) with in-process control checks at each critical step.
- Weight checks per unit
- Cannabinoid uniformity per IPC protocol
- Line clearance at each manufacturing stage
- Environmental monitoring (cleanroom class)
- Finished Product Testing
Full release test panel on finished batch per approved specifications and EU Pharmacopoeia requirements.
- Identity (HPLC), Assay: THC, CBD, terpene profile
- Microbiological: TAMC, TYMC, E. coli, Salmonella
- Pesticide residues (EU MRL)
- Heavy metals: Pb, Cd, Hg, As
- Residual solvents (extracts only)
- Moisture content (dried flower)
- All specs pass?
All finished product test results must comply with the approved product specifications and pharmacopoeial limits.
- OOS Investigation
Out-of-Specification result triggers formal OOS investigation per ICH Q7 requirements. Root cause analysis, retesting protocol, and batch disposition decision.
- Phase 1: Lab investigation (instrument, analyst)
- Phase 2: Full manufacturing investigation
- Disposition: rework, retest, or reject
- QP Review & Certification
EU Qualified Person reviews complete batch record, all test results, deviations, and GACP/GMP documentation before certifying the batch.
- Full batch manufacturing record reviewed
- All IPC results within limits
- All deviations closed and impact-assessed
- GACP + GMP certificates current
- Batch Released ✓
QP-signed batch certificate issued. Product released for wholesale distribution to German pharmacies. Retain samples held for 1 year post-expiry.