- Manufacturing (GMP Site)
Cannabis manufactured at MHRA-certified or MRA-recognised GMP site. GACP certification required at cultivation stage.
- GACP Controls
Cultivation under GACP standard. UK accepts EU GACP and WHO GACP. Certification by ISO 17065-accredited body required.
- Irrigation, pesticide, growth logs
- Initial cannabinoid profiling
- Environmental monitoring records
- In-Process Controls (IPC)
Manufacturing steps with in-process checks per approved specifications and UK GMP requirements.
- Weight uniformity checks per unit
- Cannabinoid content by HPLC at IPC stages
- Line clearance records
- Environmental monitoring (Grade C/D for cannabis)
- Finished Product Testing
Full release test panel per UK pharmacopoeia and approved specifications. British Pharmacopoeia (BP) is the reference standard.
- Identity and assay: THC, CBD (HPLC)
- Microbiological: TAMC, TYMC, Salmonella, E. coli
- Pesticide residues (UK MRL basis post-Brexit)
- Heavy metals: Pb, Cd, Hg, As
- Moisture (dried flower: ≤10%)
- Residual solvents (extracts)
- All specs pass?
All results must comply with approved UK specifications and BP limits.
- OOS Investigation
Out-of-Specification investigation per MHRA expectations and ICH Q7. Full root cause analysis required before any retest.
- Phase 1 lab investigation
- Phase 2 full manufacturing investigation if required
- Batch disposition decision: reject or retest
- RPi Review & Certification
UK Responsible Person (Import) reviews complete batch record, all test results, GACP/GMP certificates, and Home Office import license before certifying.
- Full batch record reviewed
- All deviations closed
- GACP and GMP certificates current and in scope
- Home Office import license valid for this shipment
- Batch Released ✓
RPi-signed certificate issued. Product available for supply to licensed UK pharmacies against specialist Schedule 2 prescriptions.