GMP vs GACP: BfArM Makes some Clarifications

Following the previously adjusted specifications for medicinal Cannabis, the German BfArM makes some further clarifications regarding GMP requirements. Amongst others, the following information should be provided in the application for authorization of the irradiation treatment:

• Manufacturer: A valid GMP certificate must be included with the drying step.
• Definition of the packaging material in which the cannabis flowers are placed on the market.
• Decontamination: The irradiating company must have a valid GMP certificate.
• Bioburden: The microbial load at which irradiation is carried out should be specified.
• The irradiation procedure has to be validated (e.g. validation results with different water contents of the plant material).
• Information on whether there are studies showing that the spectrum of ingredients is not altered by irradiation.
• Information on microbial count reduction measures implemented during cultivation.
• Description and validation of all analytical methods.
• If available, stability data on the stability of irradiated and non-irradiated cannabis flowers.
• Certificates of analysis (CoAs).

For more information please see Allgemeine Hinweise zum Antrag auf Zulassung von Arzneimitteln, die zur Verminderung der Keimzahl mit ionisierenden Strahlen behandelt worden sind (§ 7 AMG und § 1 AMRadV).