Malta Flags GMP Violations at Two South African Cannabis Facilities

Malta’s Medicines Authority issued two EU GMP non-compliance reports for South African sites tied to cannabis-based medicinal products. One was a manufacturer of cannabis flower in 10g pouches; the other, a QC lab analyzing non-sterile dosage forms.

The manufacturer inspection revealed 3 critical and 5 major deficiencies, including poor equipment qualification, inadequate process validation, and limited GMP expertise in QA. Other issues involved weak risk assessments, documentation, and sampling practices.

The QC lab inspection found 4 critical and 3 major issues, including failures in validation, QC testing, and data integrity tied to IT system backups and deviation management.

Due to the severity of findings, EU GMP certification was denied. EU Member States are advised to avoid using these sites in marketing authorization applications until further notice.

30-06-2025