Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018
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4 Definitions
Note: A number of expressions used in this instrument are defined in the Act, including the following:
(a) British Pharmacopoeia;
(b) default standard;
(c) European Pharmacopoeia;
(d) export only medicine;
(e) medicine;
(f) standard;
(g) United States Pharmacopeia-National Formulary.
In this instrument:
acceptance criteria, in relation to microbiological quality, are interpreted as:
(a) 101 CFU: maximum acceptable count is 20;
(b) 102 CFU: maximum acceptable count is 200;
(c) 103 CFU: maximum acceptable count is 2000, and so forth.
Act means the Therapeutic Goods Act 1989.
antimicrobial preservation means the presence of an ingredient(s) in a medicine that inhibits the growth of microorganisms in the medicine.
CFU means colony forming units.
complementary medicine has the same meaning as in the Regulations.
herbal substance has the same meaning as in the Regulations.
monograph means the requirements of an individual or general monograph in a default standard read in conjunction with the General Notices contained in the same edition that are applicable to that monograph.
Regulations means the Therapeutic Goods Regulations 1990.