GMP non-Compliance Reports for two Cannabis Sites

Malta's Medicines Authority recently issued two GMP non-compliance statements: One  to a manufacturer of cannabis-based medicinal products (Cannabis flower in 10g patient pouches) and another to a Quality Control (QC) testing laboratory for the analytical testing of non-sterile dosage forms (specifically for medical Cannabis products).

Non-Compliance with EU GMP

The South African manufacturing site was inspected against EU GMP Part 1 for Medicinal Products. During the inspection three critical and five major deficiencies were identified, including

• Inadequate facility and equipment qualification
• Insufficient process validation
• Limited GMP expertise within Quality Assurance (QA)

Major issues also involved poor risk assessments, weak documentation and data integrity controls. Furthermore, deficiencies in line clearance, deviation management, and sampling practices were detected. 

The inspection of the Quality Control (QC) testing laboratory (also located in South Africa) resulted in the identification of four critical and three major deficiencies. The critical findings were concerned with Validation and Qualification activities and QC Chemistry and Micro analytical operations. The major deficiencies were related to risk considerations and risk assessments, deviation management and IT systems and their back-ups with serious data integrity implications.

Based on these findings, it was concluded that EU Good Manufacturing Practice (GMP) certification could not be granted. Member States should consider refraining from initiating or authorizing marketing authorization applications that list the inspected sites as a finished medicinal product manufacturing / analysis site whilst the non-compliance statement remains in place.

More information is available in the GMP non-compliance statements issued by the Malta Medicines Authority (EudraGMDP Ref Key 177533 & 177261).