Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018
made under section 10 of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 28 March 2022
Includes amendments up to: F2022L00384
Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018
made under section 10 of the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 28 March 2022
Includes amendments up to: F2022L00384
About this compilation
This compilation
This is a compilation of the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018 that shows the text of the law as amended and in force on 28 March 2022 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
1 Name
3 Authority
4 Definitions
5 Incorporation by reference
6 Application
7 General exemptions
9 Sterility and Bacterial Endotoxin testing
10 Efficacy of antimicrobial preservation of a multidose medicine
11 Microbiological attributes of a non-sterile medicine
Schedule 1— Microbial attributes for a complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin
Schedule 2— Microbial attributes for a complementary medicine oral dosage form containing raw material of natural (vegetal) origin that is a herbal medicinal product consisting solely of one or more herbal substances (whole, reduced or powdered) to which boiling water is added before use
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
(1) This instrument is the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018;
(2) This instrument may also be cited as Therapeutic Goods Order 100, or TGO 100.
This instrument is made under section 10 of the Therapeutic Goods Act 1989.
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.
Where a default standard adopts a different name or number for a test or method that is referenced in this instrument, this instrument incorporates that renamed or renumbered test or method.
(1) The requirements set out in this instrument apply to all therapeutic goods that are medicines.
(2) However, the requirements set out in this instrument do not apply to a medicine that is exempt under section 7 of this instrument.
The requirements of this instrument do not apply to a medicine that:
(a) is an export only medicine; or
(b) is imported into Australia for use in the treatment of the importer or the importer’s immediate family, in accordance with item 1 of Schedule 5 to the Regulations; or
(c) is a starting material used in the manufacture of medicines, except when:
(i) pre-packaged for supply for other therapeutic purposes; or
(ii) formulated as a dosage form; or
(d) the starting material has not reached its final stage of manufacture; or
(e) is a medicine to which the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 applies.
Note: Microbiological standards for medicinal cannabis products are outlined in the Therapeutic Goods Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017.
9 Sterility and Bacterial Endotoxin testing
Where:
(a) a medicine is required to be sterile or to comply with a bacterial endotoxin test by an individual or general monograph of a default standard; or
(b) a medicine through its labelling or packaging states or implies that the medicine is sterile,
the medicine must comply with the Test for Sterility and, if applicable, the Bacterial Endotoxin Test, of a default standard.
10 Efficacy of antimicrobial preservation of a multidose medicine
A medicine that is an aqueous multidose medicine must comply with the British Pharmacopoeia, Appendix XVI C. Efficacy of Antimicrobial Preservation or the European Pharmacopoeia, Efficacy of Antimicrobial Preservation (5.1.3), except that an aqueous multidose medicine that is a liquid oral antacid medicine may comply with the relevant test in the United States Pharmacopeia – National Formulary, chapter <51> Antimicrobial Effectiveness Test including its acceptance criteria.
11 Microbiological attributes of a non-sterile medicine
(1) A non-sterile medicine, other than a complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin, 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.
(2) A complementary medicine oral dosage form containing raw material of natural (animal, vegetal or mineral) origin must comply with the acceptance criteria for microbiological quality specified in Schedule 1 when tested by a method stated in subsection 11(1), other than a herbal medicine consisting solely of one or more herbal substances (whole, reduced or powdered) to which boiling water is added before use, which must comply with the acceptance criteria specified in Schedule 2 when tested with a method mentioned in subsection 11(1).
(subsection 11(2))
1 Table of acceptance criteria
Microbiological Quality | Acceptance Criteria |
Total aerobic microbial count | Less than or equal to 104 CFU per g or per mL |
Total yeast and mould count | Less than or equal to 102 CFU per g or per mL |
Bile-tolerant Gram negative bacteria | Less than or equal to 102 CFU per g or per mL |
Salmonella | absent in 10 g or 10 mL |
Escherichia coli | absent in 1 g or 1 mL |
Staphylococcus aureus | absent in 1 g or 1 mL |
(subsection 11(2))
1 Table of acceptance criteria
Microbiological Quality | Acceptance Criteria |
Total aerobic microbial count | Less than or equal to 107 CFU per g |
Total yeast and mould count | Less than or equal to 105 CFU per g |
Bile-tolerant Gram negative bacteria | Less than or equal to102 CFU per g |
Escherichia coli | absent in 1 g |
Salmonella | absent in 10 g |
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
ad = added or inserted | o = order(s) |
am = amended | Ord = Ordinance |
amdt = amendment | orig = original |
c = clause(s) | par = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
Ch = Chapter(s) | pres = present |
def = definition(s) | prev = previous |
Dict = Dictionary | (prev…) = previously |
disallowed = disallowed by Parliament | Pt = Part(s) |
Div = Division(s) | r = regulation(s)/rule(s) |
exp = expires/expired or ceases/ceased to have | reloc = relocated |
effect | renum = renumbered |
F = Federal Register of Legislation | rep = repealed |
gaz = gazette | rs = repealed and substituted |
LA = Legislation Act 2003 | s = section(s)/subsection(s) |
LIA = Legislative Instruments Act 2003 | Sch = Schedule(s) |
(md) = misdescribed amendment can be given | Sdiv = Subdivision(s) |
effect | SLI = Select Legislative Instrument |
(md not incorp) = misdescribed amendment | SR = Statutory Rules |
cannot be given effect | Sub‑Ch = Sub‑Chapter(s) |
mod = modified/modification | SubPt = Subpart(s) |
No. = Number(s) | underlining = whole or part not |
| commenced or to be commenced |
Name | Registration | Commencement | Application, saving and transitional provisions |
Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018 | 07 Dec 2018 | 08 Dec 2018 | |
Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Amendment Order 2022 | 25 Mar 2022 | 28 Mar 2022 | |
Provision affected | How affected |
s 2..................... | rep LA s 48D |
s 7..................... | am F2022L00384 |
s 8..................... | rep LA s 48C |
Sch 3................... | rep LA s 48C |