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In-line & Release Testing

SÚKL and EU-GMP QC requirements

Testing & QC Verified 2026-04-20

Workflow steps

  1. Manufacturing (EU-GMP Site)
    Cannabis manufactured at EU-GMP Part I certified site. Czech Pharmacopoeia and European Pharmacopoeia are reference standards.
  2. GACP Controls
    EU GACP or WHO GACP certification required.
    • Pesticide logs — EU MRL basis
    • Harvest moisture ≤10%
    • ISO 17065-accredited certifier
  3. Finished Product Testing
    Full release panel per EU Pharmacopoeia and Czech Pharmacopoeia.
    • Identity and assay: THC, CBD (HPLC)
    • Microbiological per Ph. Eur.
    • Pesticide residues (EU MRL)
    • Heavy metals per Ph. Eur. 2.4.27
    • Moisture content
  4. All specs pass?
    Results must comply with SÚKL-approved specifications.
  5. OOS Investigation
    OOS investigation per EU-GMP and SÚKL expectations.
    • Phase 1 lab + Phase 2 manufacturing investigation
    • SÚKL notification if released batch affected
  6. Czech QP Release
    QP certifies batch for Czech market release.
    • Full batch record reviewed
    • All certificates current
  7. Batch Released ✓
    Available for Czech pharmacy supply.
Export / Import Process