EU-GMP Post-Harvest Facility in South Africa
Engineering design, C&Q, computerized system validation and EU-GMP readiness for Asif 420 (WeGrow)'s medical cannabis post-harvest and packaging facility, built for export to Germany and the UK.
URS/BOD/DQHVAC & utilitiesEquipment IQ/OQCSVQMSMock audits
The Brief
A high-throughput post-harvest processing, drying and packaging facility in South Africa, designed to EU-GMP so its products can enter the German and UK pharmaceutical markets.
What We Did
- Engineering design: URS, basis of design and DQ; personnel, material and waste flows, cleanroom class boundaries and temperature and humidity limits.
- HVAC and clean utilities: design and qualification of the HVAC, purified water and oil-free compressed air (URS, IQ/OQ/PQ).
- Process equipment: specified the automated trimming, packaging and labeling lines and wrote their qualification (URS, IQ/OQ, VSR).
- Computerized systems (CSV): validated the automation control panels and the eQMS to 21 CFR Part 11 and EU-GMP.
- QA and audit readiness: a pharmaceutical-grade QMS with GACP, IMC-GAP and EU-GMP procedures, process and cleaning validation, temperature and humidity mapping, and mock audits before the inspection.
Result
A validated, audit-ready facility prepared for commercial export to European markets.
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