Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017
16Microbiological attributes
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16 Microbiological attributes
A medicinal cannabis product that is in oral dosage form or for administration by inhalation must comply with the relevant acceptance criteria for microbiological quality of one of the following:
(a) the British Pharmacopoeia, Appendix XVI. D Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use, when tested by the methods of:
(i) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 2. Microbial Enumeration Tests; and
(ii) the British Pharmacopoeia, Appendix XVI B. Microbiological Examination of Non-Sterile Products: 1. Test for Specified Micro-organisms; or
(b) the European Pharmacopoeia, Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use (5.1.4), when tested by the methods of:
(i) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests (2.6.12); and
(ii) the European Pharmacopoeia, Microbiological Examination of Non-Sterile Products: Test for Specified Micro-organisms (2.6.13); or
(c) the United States Pharmacopeia–National Formulary, chapter <1111>, MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE, when tested by the methods of:
(i) the United States Pharmacopeia–National Formulary, chapter <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS; and
(ii) the United States Pharmacopeia–National Formulary, chapter <62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS; or
(d) the Special European Pharmacopoeia (Ph. Eur.) provision for oral dosage forms containing raw materials of natural (animal, vegetal or mineral) origin for which antimicrobial pre-treatment is not feasible and for which the competent authority accepts TAMC of the raw material exceeding 1000 CFU per g or CFU per mL.