Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 is built around a small set of recurring legal and technical concepts. These are defined and used to tie a medicine to an externally authored testing protocol and numeric acceptance criteria.

Key definitional and structural concepts in the instrument:

• Default standards and monographs. The Order repeatedly applies and incorporates tests and acceptance criteria from default standards, specifically the British Pharmacopoeia, the European Pharmacopoeia and the United States Pharmacopeia-National Formulary (s 4 note; s 11). The instrument treats a "monograph" as the requirements of an individual or general monograph in a default standard read in conjunction with the General Notices in the same edition (s 4).
• Incorporation by reference. The instrument expressly incorporates renamed or renumbered tests if a default standard adopts a different name or number for a referenced method (s 5). This has the practical effect that the identity of the test follows the default standard even if the standard updates labelling or numbering.
• Scope and exemptions. The Order applies to "all therapeutic goods that are medicines" (s 6(1)) but lists explicit exceptions (s 6(2); s 7). Exemptions include export-only medicines, products imported for personal use under Schedule 5 item 1 of the Regulations, certain starting materials unless pre-packaged or formulated as a dosage form, non-final-stage starting materials, and medicines governed by TGO 93 (medicinal cannabis) (s 7).
• Sterility and endotoxin requirements. If a medicine is required to be sterile under a default standard monograph or its labelling implies sterility, it must comply with the Test for Sterility and, where applicable, the Bacterial Endotoxin Test from a default standard (s 9).
• Antimicrobial preservation. Aqueous multidose medicines must comply with BP Appendix XVI C or Ph. Eur. 5.1.3 (s 10). An explicitly carved-out exception permits liquid oral antacid aqueous multidose medicines to use USP <51>, including its acceptance criteria.
• Microbiological attributes for non-sterile medicines. Non-sterile medicines (other than certain complementary medicine oral dosage forms containing raw natural materials) must meet the acceptance criteria in one of three pharmacopoeial options: BP Appendix XVI.D, Ph. Eur. 5.1.4, or USP-NF chapter <1111>, each when tested by the matching enumeration and specified-organism test methods cited (s 11(1)).
• Complementary medicine exceptions and bespoke thresholds. Complementary medicine oral dosage forms that contain raw material of natural origin are subject to bespoke acceptance criteria in Schedule 1; a subset of herbal products prepared by adding boiling water are subject to the different, higher-count limits in Schedule 2. In both cases the testing method must be one of the methods listed in s 11(1) (s 11(2); Schedules 1 and 2).
• Acceptance criteria interpretation. The instrument sets a discrete interpretive rule for reading "10^1 CFU", "10^2 CFU", "10^3 CFU" etc., mapping each notation to a maximum acceptable count (s 4). That interpretive rule applies where acceptance criteria are expressed using the 10^n notation.

These concepts make the Order a technical overlay: it does not create new testing techniques but prescribes which existing standards and numeric thresholds apply in the Australian regulated space for medicines. Its effect depends on locating the correct default-standard monograph and applying the enumerated test-method pairings and the bespoke acceptance thresholds in Schedules 1 and 2 where applicable.

The instrument applies to "all therapeutic goods that are medicines" (s 6(1)). It therefore interacts with every actor in the medicine supply chain in Australia whose product falls within that statutory category, subject to the explicit exemptions (s 7). The text does not nominate such actors by label, but the operational consequences identify the groups that must act to comply.

Principal affected categories, as derived from the text:

• Products in scope. All medicines as defined under the Act are within the instrument's reach unless an exemption applies (s 6(1); s 7). The Order explicitly excludes export-only medicines (s 7(a)) and medicines imported under a specific personal-use exemption in Schedule 5 to the Regulations (s 7(b)). It also excludes most starting materials that have not reached final manufacture, except where a starting material is pre-packaged for supply for other therapeutic purposes or is formulated as a dosage form (s 7(c)(i)-(ii); s 7(d)).
• Complementary medicine manufacturers and sponsors. Complementary medicine oral dosage forms that incorporate raw natural materials (animal, vegetal or mineral origin) are subject to Schedules 1 or 2 (s 11(2); Schedules 1 and 2). Those product sponsors, manufacturers or suppliers will need to apply the bespoke thresholds and to perform testing using the method options in s 11(1).
• Manufacturers of sterile products and those claiming sterility. Any medicine that is required by a default standard to be sterile, or that is labelled or presented as sterile, must comply with the Test for Sterility and with the Bacterial Endotoxin Test where applicable (s 9). Entities that label products as sterile will therefore be affected by the procedural and testing requirements.
• Manufacturers and sponsors of aqueous multidose medicines. Aqueous multidose medicines must satisfy antimicrobial preservation tests in BP Appendix XVI C or Ph. Eur. 5.1.3, with an express alternative for liquid oral antacids to follow USP <51> (s 10). Suppliers of such multiuse products will be directly affected.
• Entities producing non-sterile pharmaceutical preparations. For non-sterile medicines (other than the complementary-medicine exceptions), compliance can be achieved via one of three pharmacopoeial regimes (s 11(1)). Entities must choose and test according to one pharmacopoeial pathway and relevant test methods specified.
• Regulators and assessors. Although the instrument does not itself contain enforcement provisions, its technical specifications will be used by the regulatory authority and assessors when evaluating conformity of medicines with the Act and Regulations (s 3; s 4 note; s 11). The instrument therefore affects how regulatory review and conformity assessments will be performed.

Who pays and who implements. The instrument places substantive technical obligations on the products; the practical cost of testing, testing methods, and any reformulation or labelling changes will fall on the persons or entities responsible for bringing the medicines to the Australian market. The Order does not itself allocate inspection or enforcement resource responsibilities; enforcement will flow through the Act and the broader regulatory system (s 3).

Who is not affected. The instrument excludes export-only medicines (s 7(a)) and products covered by TGO 93 for medicinal cannabis (s 7(e)). It also excludes starting materials that have not reached final manufacture, except where those materials are packaged or formulated as supply items (s 7(c)-(d)).

TGO 100 imposes prescriptive duties on medicines in scope by specifying testing obligations, test methods and acceptance criteria. The Order does not create express procedural rights or appeal mechanisms; those are matters for the Act and the Regulations. Below are the principal duties, their textual source and the immediate corollary operational actions they require.

Duties arising directly from the instrument

• Duty to comply with pharmacopoeial sterility and endotoxin tests where required or claimed. If a medicine is required to be sterile by a default standard monograph, or its labelling or packaging states or implies that it is sterile, the medicine "must comply with the Test for Sterility and, if applicable, the Bacterial Endotoxin Test, of a default standard" (s 9). Operationally this requires following the sterility test procedures in the referenced default standard and performing any endotoxin testing the monograph requires.
• Duty to demonstrate antimicrobial preservation efficacy for aqueous multidose medicines. 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)" (s 10). There is an explicit, permitted deviation for liquid oral antacid aqueous multidose medicines to use USP <51> (s 10).
• Duty to meet microbiological quality acceptance criteria for non-sterile medicines via a specified pharmacopeial pathway. A non-sterile medicine (other than the complementary-medicine oral dosage exception) "must comply with the relevant acceptance criteria for microbiological quality" from one of three listed pharmacopoeial sources and be tested by the specified enumeration and specified organism methods paired with each acceptance-criteria statement (s 11(1)(a)-(c)). This imposes a duty to select an appropriate default standard pathway and to apply the corresponding test methods.
• Duty to apply Schedules 1 or 2 for complementary medicine oral dosage forms containing raw natural materials. Where the product is a complementary medicine oral dosage form that contains raw natural (animal, vegetal or mineral) material, it "must comply with the acceptance criteria for microbiological quality specified in Schedule 1 when tested by a method stated in subsection 11(1)" (s 11(2)). If the product is a herbal medicinal product consisting solely of herbal substances to which boiling water is added before use, it must instead comply with Schedule 2 when tested with a method mentioned in s 11(1). This is a categorical duty for those classes of products.
• Duty to interpret numerical acceptance criteria according to the instrument’s interpretation rule. The Order provides an interpretive rule for "acceptance criteria, in relation to microbiological quality" mapping 10^1, 10^2, 10^3 notation to maximum acceptable counts (s 4). This duty is to apply the interpretive mapping where those notations appear.

Rights and implied procedural points in the text

• Right to choose one of the listed pharmacopoeial pathways for non-sterile products. For non-sterile medicines the instrument gives multiple routes to compliance: BP Appendix XVI.D, Ph. Eur. 5.1.4 or USP-NF chapter <1111> (s 11(1)). That grants regulated entities flexibility to use the pharmacopoeial system that best fits their product development, provided they use the corresponding test methods.
• Right to rely on the instrument’s incorporation of renamed or renumbered methods. Section 5 ensures that if a default standard adopts a different name or number for a referenced test, the instrument incorporates that change. This reduces the need for additional instrument amendments when default standards evolve in labelling or numbering, but it places a burden on the regulated entity to track those changes in the default standards themselves.

Duties the instrument does not specify

• The instrument is silent about enforcement steps, timeframes for testing, accreditation of laboratories, who certifies compliance, or notification procedures. Those matters are left to the Act and the regulatory framework more broadly (s 3). The instrument prescribes substance and method, not process.

In short, the Order creates mandatory substantive obligations to perform specified pharmacopoeial tests and meet numeric thresholds for medicines in scope, and gives product sponsors discrete options for certain product classes. It provides interpretive clarity on CFU notation and accommodates changes by default standards through incorporation by reference.

TGO 100 is a technical standards instrument; it does not itself set out penalties, sanctions or enforcement procedures. The Order is made under s 10 of the Therapeutic Goods Act 1989 (s 3), and its obligations should be enforced under the powers and penalties available in that Act and relevant Regulations. The instrument’s text contains no penalty clauses, no infringement notice regime, no administrative decision-making provisions, and no domestic enforcement steps.

What follows from the text:

• Enforcement framework resides in the Act and Regulations. Because the Order is made under s 10 of the Act (s 3), the penalties and enforcement mechanisms applicable to failures to comply with statutory instruments under the Act will be those established by the Act and Regulations. The instrument itself does not specify which particular Act provisions will be invoked or how regulatory discretion is to be exercised.
• No instrument-level inspection, laboratory accreditation or notification requirements. TGO 100 prescribes tests and acceptance criteria but provides no procedural directions for who performs testing, how test results are to be reported to the regulator, what laboratory accreditation is required or how compliance will be certified. Those procedural matters are properly addressed elsewhere in the regulatory framework, but they are not contained in this instrument.
• Risk of administrative action or regulatory sanctions remains external to the Order. Because the Order sets binding technical requirements for medicines in scope, failure to comply with the Order’s specified tests or numerical limits will be a breach of the regulatory obligations that apply under the Act; the instrument itself does not delineate the consequences. The precise enforcement steps, including inspection powers, seizure, recall, suspension of supply or civil and criminal penalties, are matters for the Act and Regulations.

For practitioners and compliance officers this means:

• The technical standard must be met to be able to demonstrate conformity. Failure to satisfy the instrument’s test and acceptance requirements will expose the medicine sponsor or manufacturer to regulatory action under the Act, although the mechanism and scale of action are not set out in the Order itself (s 3).
• Administrative discretion and enforcement practice will be governed by other legal instruments and regulatory policy. Users of the Order will need to consult the Act, the Regulations and relevant regulator guidance to determine enforcement risk, notification obligations and procedural rights.

In short, TGO 100 sets substantive obligations; it does not, on its face, set enforcement instruments or penalties. Those are to be found in the parent statute and the wider regulatory framework.

TGO 100 is expressly framed to operate within the statutory architecture created by the Therapeutic Goods Act 1989 and the associated Regulations and default standards. The instrument references and depends upon other legal and technical texts in multiple ways.

Direct statutory and regulatory interactions

• Made under the Act. The instrument is made under s 10 of the Therapeutic Goods Act 1989 (s 3). It therefore derives its legal force from the Act and must be applied in the context of the Act’s definitions, powers and regulatory mechanisms (s 4 note refers to definitions in the Act).
• References to the Regulations. The instrument relies on definitions that are in the Regulations, for example "complementary medicine" and "herbal substance" which the instrument notes have the same meaning as in the Regulations (s 4). It also refers to Schedule 5 to the Regulations when specifying a personal import exemption (s 7(b)).
• Interaction with other Therapeutic Goods Orders. The instrument explicitly excludes medicines to which the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 applies (s 7(e)). This creates a regime separation: medicinal cannabis products are governed by TGO 93 rather than by the microbiological specifications in TGO 100.

Technical and standards interactions

• Incorporation of default standards. The instrument imposes obligations by reference to default standards (BP, Ph. Eur., USP-NF) and to specific monographs, appendices and chapters within those standards (s 4 note; s 9; s 10; s 11). This means the instrument’s technical requirements cannot be fully applied without consulting the relevant edition of the default standard for the monograph and associated General Notices (s 4 definition of "monograph").
• Renaming or renumbering. Section 5 ensures the instrument follows a default standard’s renaming/renumbering of tests. This reduces the risk of textual mismatch between TGO 100 and subsequent editions of the default standards, but it anchors the instrument to the content of external standards.
• Testing method pairings. The instrument does not simply copy acceptance numbers; it pairs acceptance criteria with the enumeration and specified-organism methods in the same pharmacopoeial system (s 11(1)). For example, BP acceptance criteria must be tested by BP Appendix XVI B methods, Ph. Eur. criteria must be tested by Ph. Eur. methods 2.6.12 and 2.6.13, and USP <1111> criteria must be tested by USP <61> and <62> (s 11(1)(a)-(c)). This coupling creates a linked legal-technical regime that blends a numeric outcome with a particular method.
• Editions and General Notices. Because the instrument defines "monograph" to include the General Notices in the same edition applicable to that monograph (s 4), compliance requires attention to the edition of the pharmacopoeia used and to any General Notices that qualify monograph requirements.

Consequences of these interactions

• Dependence on external standards for substantive content. Because the Order delegates substantive technical content to external pharmacopoeial monographs, any substantive change in those standards (apart from mere renaming/renumbering handled by s 5) may have compliance implications and may require sponsors to monitor those standards closely.
• Interplay with product labelling and packaging law. The instrument ties laboratory obligations to labelling claims: if labelling or packaging states or implies sterility, the Test for Sterility must be met (s 9). This links the instrument to the legal regimes governing claims, labelling and advertising (as contained elsewhere in the Act and Regulations).
• Narrowed overlap with medicinal cannabis regulation. The specific carve-out for TGO 93 (s 7(e)) prevents duplication or conflict between microbiological standards for cannabis and those in TGO 100. Users must choose the applicable Order depending on product classification.

In short, TGO 100 is operationally interdependent with the Act, the Regulations, other TGOs and the external pharmacopoeial standards. Correct application requires cross-referencing editions, General Notices and the relevant regulatory definitions.

The instrument identifies itself as the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018 and provides no internal amendment trail or history beyond that designation (s 1). The text supplied contains no subsequent amending provisions, transitional provisions or expiry clauses.

What the instrument says and what that implies:

• Single-instrument form. The Order’s printed sections are presented as a stand-alone instrument; there are no listed amendments, repeals or schedules beyond Schedules 1 and 2 which provide microbiological thresholds. The instrument does not document prior versions or amendment dates in the text provided.
• Incorporation mechanism reduces need for future instrument amendments for renumbering. Section 5 provides that when a default standard renames or renumbers a test or method referenced in the instrument, that renamed or renumbered test or method is incorporated. This provision reduces the likelihood that the instrument will require frequent formal amendment merely to update internal references when default standards perform technical renumbering.
• Edition sensitivity remains. Despite s 5, the instrument’s substantive content depends on the monographs and General Notices of the default standards. If a default standard changes acceptance criteria substantively, that change could have practical effect on compliance. The instrument contains no internal mechanism for freezing specific editions of default standards; instead the definition of "monograph" requires that the monograph be read with the General Notices "contained in the same edition" as the monograph (s 4). This creates a de facto link to particular editions when applying a monograph, but the instrument does not itself state which edition to use or whether a particular date/version is fixed.

Absence of a recorded amendment history in the supplied text means:

• Practitioners must treat the instrument as a current 2018 Order subject to any external amendments not printed here. The instrument text itself does not list changes.
• To determine any subsequent legislative changes or ministerial amendments to TGO 100, one must consult official legislative registers or the Federal Register of Legislation. The instrument text provided does not supply that registry information or amendment trail.

In sum, the instrument as supplied contains no internal amendment history, and s 5 provides a limited updating mechanism to accommodate renaming/renumbering in external default standards.

The TGO 100 text provided contains no references to litigation, judicial decisions, or case law. It does not cite, rely upon, or incorporate judicial interpretations. The instrument itself does not reference any litigation history, and no cases are named in the instrument text.

What that means for practitioners:

• There are no instrument-contained precedents to apply when interpreting its provisions. Interpretation will thus depend upon the instrument’s plain text, the Act, the Regulations, and any relevant regulatory guidance or external jurisprudence (not included in the instrument).
• If questions of interpretation arise (for example, whether labelling "implies" sterility in a particular context, or which edition of a default standard applies), judicial or administrative review would proceed under the usual processes governing decisions under the Act. Those procedural and jurisprudential avenues are not described in TGO 100 itself.

Because no litigation history is recorded in the instrument, any lawyer or compliance officer seeking to understand contested points will need to search external sources: regulator decisions, tribunal determinations or court judgments dealing with TGO 100 or the relevant sections of the Act. That material is not included in the instrument text provided.

The instrument contains several technical details and drafting choices that can produce compliance traps if overlooked. The following points are derived from the instrument’s text and identify potential pitfalls for sponsors, manufacturers, assessors and advisers.

1. Labelling implies sterility test trigger (s 9). The obligation in s 9 is not limited to explicit claims of sterility. If packaging or labelling "states or implies" that the medicine is sterile, the product must comply with the Test for Sterility and, if applicable, the Bacterial Endotoxin Test of a default standard. A product that uses suggestive language, imagery or packaging that could reasonably be read as denoting sterility will be brought within the sterility-testing obligation. This creates an operational link between marketing/packaging decisions and laboratory testing requirements.

2. The complementary medicine carve-out is narrow and conditional (s 11(2)). Complementary medicine oral dosage forms containing raw material of natural origin are not subject to the generic non-sterile criteria in s 11(1). Instead, they must comply with Schedule 1 (or Schedule 2 for the specific herbal-to-boiling-water products) when tested by an appropriate method. Practitioners must not apply s 11(1) thresholds mechanically to such products; they must consult Schedules 1 and 2.

3. Different acceptance thresholds across Schedules. Schedule 1 sets much tighter microbial limits for complementary medicines containing raw natural materials (for example, total aerobic microbial count ≤10^4 CFU per g or per mL; total yeast and mould count ≤10^2 CFU per g or mL) while Schedule 2 allows substantially higher counts for herbal products to which boiling water is added (for example, total aerobic microbial count ≤10^7 CFU per g). Selecting the wrong Schedule or misreading whether the product is the special herbal-prepared-by-boiling type can lead to inappropriate testing targets.

4. CFU notation interpretation rule (s 4). The instrument provides an explicit rule for interpreting CFU notations such as 10^1, 10^2 and 10^3 in relation to maximum acceptable counts. For example, "10^1 CFU: maximum acceptable count is 20". This mapping is not the straight numeric equality one might expect, and failure to apply the interpretive rule will lead to incorrect pass/fail assessments. Practitioners must apply the instrument’s interpretive rule when reading acceptance criteria.

5. Testing method must match acceptance criterion source (s 11(1)). The instrument couples each set of acceptance criteria with specific enumeration and specified-organism test methods in the same pharmacopoeial system. For example, BP Appendix XVI.D must be tested using BP Appendix XVI B methods; Ph. Eur. numbers must be tested by Ph. Eur. 2.6.12 and 2.6.13; USP <1111> must be tested by USP <61> and <62> (s 11(1)). Using a numerically equivalent acceptance limit from one pharmacopoeia but testing with another pharmacopoeia’s method is not the textual compliance route.

6. Default standard editions matter (s 4). "Monograph" includes the General Notices "contained in the same edition" applicable to that monograph (s 4). That means the user must be careful to use the monograph and General Notices from the same edition. The instrument does not specify which edition to use; the practitioner must determine the edition relied upon for a particular monograph.

7. Renaming/renumbering rule reduces but does not eliminate edition risk (s 5). Section 5 ensures renamed or renumbered tests are incorporated, but it does not address substantive technical changes to methods or acceptance criteria in new editions of the default standards. Sponsors must therefore track substantive changes in pharmacopoeial content, not just name/number changes.

8. Carve-out for medicinal cannabis (s 7(e)). Products that fall under the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 are exempt. Misclassification of a cannabis product as falling under TGO 100 rather than TGO 93 could lead to the application of inappropriate microbiological tests.

9. Exemptions for starting materials are conditional (s 7(c)-(d)). Starting materials are exempt only when they have not reached their final stage of manufacture, and the exemption ceases when a starting material is pre-packaged for supply for other therapeutic purposes or is formulated as a dosage form (s 7(c)(i)-(ii)). This places importance on the product’s manufacturing stage and its intended supply form.

10. No procedural detail for laboratories or reporting. The Order specifies what tests and thresholds apply but not who must perform them, accreditation requirements, or how test reports are to be submitted to the regulator. Practitioners must look to the Act, the Regulations and regulator guidance for procedural obligations.

Each of these points flows directly from the instrument text and indicates where misreading, misclassification or superficial application of pharmacopoeial material can create compliance failure.

The instrument prescribes substantive obligations but leaves procedural enforcement and administrative pathways to the Act and Regulations. The steps below translate the instrument’s textual duties into a practical compliance checklist, grounded in the Order’s provisions.

1. Confirm product scope and exemptions

• Determine whether the product is a "medicine" within the meaning of the Act and therefore in scope of TGO 100 (s 6(1); s 4 note).
• Check whether the product falls under any of the instrument’s exemptions: export-only medicines; product imported for personal use under Schedule 5 item 1; starting materials not at final manufacture stage (unless pre-packaged/formulated for supply); medicines governed by TGO 93 (medicinal cannabis) (s 7(a)-(e)). If an exemption applies, the instrument’s microbiological specifications do not apply.

2. Determine whether sterility or endotoxin tests are required

• If a default-standard monograph requires sterility or a bacterial endotoxin test, the medicine must comply with the Test for Sterility and, where applicable, the Bacterial Endotoxin Test of a default standard (s 9(a)).
• Independently of monographs, if the labelling or packaging "states or implies" that the medicine is sterile, the same testing obligations attach (s 9(b)). Review product labelling, packaging and promotional materials for any language, symbols or presentation that could be interpreted as implying sterility.

3. For aqueous multidose medicines, run antimicrobial-preservation testing

• If the product is an aqueous multidose medicine, perform the antimicrobial preservation efficacy test from either BP Appendix XVI C or Ph. Eur. Efficacy of Antimicrobial Preservation (5.1.3) (s 10).
• If the aqueous multidose product is a liquid oral antacid, you may instead use USP <51> Antimicrobial Effectiveness Test including its acceptance criteria (s 10). Ensure the method and acceptance criteria used are from the permitted source.

4. For non-sterile medicines, select a pharmacopoeial pathway and test methods

• For non-sterile medicines that are not the complementary-medicine oral dosage forms listed in s 11(2), choose one of the following acceptance-criteria pathways and apply the matching enumeration and specified-organism test methods:
  • British Pharmacopoeia, Appendix XVI.D, tested by BP Appendix XVI B methods (s 11(1)(a)(i)-(ii)).
  • European Pharmacopoeia, Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use (5.1.4), tested by Ph. Eur. 2.6.12 and 2.6.13 (s 11(1)(b)(i)-(ii)).
  • United States Pharmacopeia-National Formulary chapter <1111>, tested by USP <61> and <62> (s 11(1)(c)(i)-(ii)).
• Ensure the chosen pharmacopoeial monograph and its General Notices are from the same edition per the instrument’s "monograph" definition (s 4).

5. For complementary medicine oral dosage forms with raw natural material, apply Schedules 1 or 2

• If the product is a complementary medicine oral dosage form containing raw material of natural origin, apply Schedule 1 acceptance criteria when testing by a method listed in s 11(1) (s 11(2); Schedule 1). Schedule 1 sets explicit limits for total aerobic microbial count, total yeast and mould count, bile-tolerant Gram-negative bacteria, Salmonella, E. coli, and Staphylococcus aureus.
• If the product 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, apply Schedule 2 acceptance criteria when testing by a method in s 11(1) (s 11(2); Schedule 2). Schedule 2 sets different, generally higher allowable microbial counts for such herbal products.
• In both cases, testing must be performed using one of the enumeration and specified-organism methods set out in s 11(1).

6. Apply the instrument’s CFU interpretation rule where relevant

• When reading acceptance limits expressed in 10^n notation, apply the instrument’s interpretation mapping (s 4). For example, 10^1 CFU is interpreted as a maximum acceptable count of 20; 10^2 CFU maps to 200; 10^3 CFU maps to 2,000. Apply this rule when comparing laboratory results to acceptance criteria.

7. Ensure method congruence and edition control

• Use the test methods paired with the acceptance criteria in the same pharmacopoeial system. Do not mix BP acceptance numbers with USP methods, for example (s 11(1)).
• Confirm the edition of the pharmacopoeia being used. Read monographs together with the General Notices contained in the same edition, as required by the definition of "monograph" (s 4). If the default standard renames or renumbers a test, s 5 incorporates the renamed/renumbered method.

8. Document and retain test evidence for regulatory review

• The Order requires compliance with specified tests and thresholds; while it does not prescribe reporting procedures, retain laboratory reports, method versions, edition references, and documentation showing that the chosen pharmacopoeial pathway was applied. These documents will be needed to demonstrate conformity in regulatory assessments under the Act (s 3; s 4).

9. Align labelling and packaging to regulatory expectations

• Review labelling, packaging and promotional claims for any language or presentation that could be read as implying sterility, unless sterility testing is intended and performed. Because labelling that "states or implies" sterility triggers the sterility test obligations, changes in packaging or marketing can change testing obligations (s 9).

10. Coordinate with regulatory counsel or the regulator on borderline cases

• For products that sit near the scope exclusions (for example, starting materials at or approaching final manufacture, or cannabis products), or when the correct pharmacopoeial edition is unclear, seek regulatory clarification. The instrument itself does not provide procedural dispute resolution or administrative pathways; those matters will be handled under the Act and the regulator’s administrative processes (s 3).

These steps track directly from the instrument’s text. They focus on identifying whether the Order applies, selecting the permitted testing pathways, applying the correct numerical thresholds, ensuring method and edition congruence, and linking labelling choices to testing obligations. Procedural compliance,notifications, enforcement timelines, and appeals,must be navigated through the Act, the Regulations and any regulator guidance rather than through the Order itself.