Therapeutic Goods Orders (TGO) – Australia Label/Quality Standards

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Medicines & Devices, Labeling, Quality & Distribution • Regulatory Affairs, QA/QC, Packaging, Manufacturing, Supply Chain

Therapeutic Goods Orders (TGOs) are legally enforceable standards used in Australia to set binding requirements for therapeutic goods. In practice, TGOs specify what must appear on packaging and labels, how quality is defined and demonstrated, when child‑resistant features apply, how to present critical warnings, and what supporting evidence manufacturers and sponsors must maintain. Operationally, TGOs are not “documents on a shelf”—they are controls that must be embedded into label artwork, label verification, batch release workflows (Lot Release), stability and storage statements (Stability Studies, Expiry Control), and distribution processes governed by GDP. When implemented well, a plant’s QMS makes compliance to TGOs routine and demonstrable.

“A TGO is only as good as the gate that enforces it—if an outdated label can still print, compliance is already lost.”

1) What TGOs Are—and What They Are Not

Are: legislative standards that prescribe labeling content and format, quality attributes, packaging requirements (including child‑resistant features where applicable), and the information sponsors must communicate to professionals and consumers. TGOs are harmonized with broader quality frameworks and are enforced at release and post‑market via inspections and recalls governed by your QMS.

Are not: optional guidance, marketing preferences, or “nice‑to‑have” statements. They do not replace internal procedures; they set minimums that your procedures—SOPs, Policies, and records—must operationalize and prove.

2) Scope of TGO Requirements—The Moving Parts

TGOs typically span four operational domains:

• Labeling & leaflets: identity, strength, dosage form, route, batch/expiry, storage conditions, critical warnings, serialization/traceability fields, and readability/legibility criteria tied to Labeling Control.
• Quality standards: specifications and test expectations reflected in QC testing, method validation, LIMS/ELN, and the release packet (CoA).
• Packaging & child‑resistant features: line setup, verification, and functional checks linked to Line Clearance and Dual Verification where risk dictates.
• Storage & distribution: mandatory storage statements and temperature constraints mapped into the WMS with FEFO, supported by temperature mapping and GDP controls.

Some TGOs focus on labeling (what must be said and how), others on product quality expectations (what must be met and evidenced). Your implementation should treat both as executable requirements—gates in MES/WMS, not checkboxes on a form.

3) Label Master Data—Make TGO Fields First‑Class

Convert TGO‑mandated fields into governed master data that drive your templates and scanners. Examples include medicine/device identity, dosage strength and form, route, pack count, sponsor details, batch/expiry print logic, storage statements, warning panels, and traceability identifiers (e.g., GS1 GTIN, unit Serialization, case/pallet SSCC). Control this data under Document Control with effective dating, change reasons, and approvals via Approval Workflow.

Do not embed TGO‑sensitive text directly in artwork files where it’s easy to drift. Structure your Labeling Control so templates pull variables at print time; require version synchronization with the current bill of materials (BOM) and batch metadata from eBMR.

4) Barcodes, Data Carriers & Logistics Labels

Australia’s supply chain is GS1‑centric. Even where a TGO prescribes human‑readable elements, your distribution efficiency and recall readiness depend on robust data carriers. Use item‑level GTIN, lot/batch and expiry encoding as applicable, and case/pallet hierarchy using GS1‑128 Case Labels and SSCC. For devices, harmonize with UDI expectations (see also US 21 CFR Part 830 for framing) and publish hierarchical events via EPCIS to strengthen downstream verification and recalls.

Every print should pass barcode/UDI checks before pack closure. Consider Machine Vision for layout/legibility rules and 100% inspection of critical fields where TGOs require prominence and minimum text height.

5) The Evidence Pack Behind TGO Labels

TGO statements on labels (e.g., storage, dosage directions, warnings) must be backed by data. Assemble a repeatable “evidence pack” for each SKU that includes: the current approved text master; artwork templates and change history; stability protocol/results supporting storage and shelf life; release criteria and CoA; key IPC and finished product tests; method validation summaries; and proof of pack‑line verification (pre‑flight, line clearance, label scans, rejects) captured in the eBMR.

Devices and combination products add design controls and risk management outputs—incorporate PFMEA and QbD rationale where they inform warnings and use‑instructions, and tie to Verification/Validation reports.

6) Small Containers, Multi‑Panel Labels & Readability

Practical constraints—ampoules, vials, blisters, sachets—do not reduce obligations. Where space is limited, use multi‑panel or peel‑back labels and ensure critical fields remain visible per the applicable TGO. Tactically, store long text off the artwork as governed variables; let the printer compose final panels so you can reflow content without violating controlled wording. Verify placement and minimum text sizes with vision systems and record outcomes in the batch.

7) Stability, Storage, and Shelf Life—Words that Match the Cold Chain

Storage conditions printed under a TGO must reflect proven product behavior. Generate and maintain the stability data set (real‑time/accelerated), translate it into clear label statements, and then operationalize the same rules in your warehouse using WMS location classes, FEFO, and temperature zone controls validated through Temperature Mapping. Tie excursion handling to Deviation/CAPA with QA decision and relabeling rules where required.

8) From Receipt to Ship—Controls that Preserve TGO Truth

Ensure TGOs survive the warehouse journey. At Goods Receipt, verify printed items and leaflets under Incoming Inspection and place stock under Hold until Component Release. Use Directed Put‑Away and segregated zones to prevent cross‑mixing (Cross‑Contamination Control). For order fulfillment, enforce Directed Picking, FEFO, and market‑specific label checks at pack & ship. Close cases/pallets with GS1‑128 identifiers and publish EPCIS events to downstream partners.

Synchronize shipping documentation—ASN, Shipping Manifest, and Bill of Lading—with the same identity, lot/expiry, and storage statements printed on labels. That alignment protects OTIF and reduces customs queries.

9) QA Disposition—Blocking the Wrong Label from Moving

Make Hold/Release status your simplest, strongest tool. If label version, warnings, or storage statements do not match the current TGO‑driven standard, stock stays in Quarantine. Tie disposition to Lot Release decisions with e‑signatures and audit trails. Downstream systems (WMS, MES) must refuse issue/pick until QA says “go”.

10) Data Integrity & Validation—Proving Compliance Without Rework

Electronic records supporting TGO compliance must withstand inspection. Operate under Part 11/Annex 11 principles, implement risk‑based CSV per GAMP 5, and qualify pack‑line devices with IQ/OQ/PQ. Keep immutable audit trails for artwork edits, print jobs, rejects, and disposition, and retain records per Record Retention rules.

11) Suppliers, Printers & CMOs—Make Requirements Enforceable

Push TGO obligations into your external network. Govern expectations via Quality Agreements, qualify partners through Vendor Qualification, monitor with Layered Process Audits, and correct with SCAR. At receipt, verify printed materials by Incoming Inspection and enforce barcoding specs (Verification).

12) Post‑Market Signals—Fast Words, Faster Gates

Safety signals and quality trends must propagate quickly to labels that TGOs govern. Use RCA, implement CAPA, and route wording adjustments through MOC. Re‑verify printers, re‑train operators via your Training Matrix, and block legacy artwork at pack with hard gates.

13) Roles, Access & Training—Who Does What

Define ownership: Regulatory authors the standard text; QA governs change, approval, and audits; Packaging executes; IT/OT maintains validated systems; Supply Chain enforces storage and labeling in distribution. Gate privileges via User Access Management and prove competency in the Training Matrix. Shared logins and ad‑hoc edits are integrity risks—retire them.

14) Metrics that Prove TGO Control

• Label–Standard Match Rate: % of packs where printed labels match current TGO‑driven template variables.
• Artwork Change‑to‑Market Lead Time: days from approved wording to first compliant batch shipped.
• Line Verification Pass Rate and reject ratio at pack (Verification).
• Temperature Excursions vs. label storage statements (Mapping, GDP).
• APR/PQR Implementation Rate: % product information updates executed after APR/PQR findings.
• Recall Readiness: time to compile label proof + EPCIS/EDI events for a given lot.

15) Common Failure Patterns (and How to Fix Them)

• Label drift. Artwork updated, variable master not. Fix: make labels consume governed variables; block print if variable set is out of date (Hard Gating).
• Shadow templates at CMOs. Partners use old PDFs. Fix: controlled distribution, print‑at‑source verification, and SCAR where drift is found.
• Unreadable small‑container text. Fix: multi‑panel/peel‑back labels verified by vision with minimum text metrics recorded.
• Storage words ≠ warehouse reality. Fix: tie statements to WMS zones and FEFO; quarantine excursions through Deviation.
• Weak release governance. Fix: enforce QA Disposition and block movement until status is Released.

16) 90‑Day Implementation Playbook

• Weeks 1–3: Catalogue applicable TGOs by SKU/market. Map each requirement to a template variable or control point. Lock text and variables under Document Control.
• Weeks 4–6: Centralize Labeling Control and wire printers to pull governed variables. Stand up in‑line verification and reject logic.
• Weeks 7–9: Align warehouse storage zones to printed statements (zones, bin logic), validate with mapping, and enforce Directed Picking/FEFO.
• Weeks 10–12: Train roles (Training Matrix), execute a mock recall using EPCIS events, and run an Internal Audit from artwork change to shipment.

17) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform turns TGO rules into executable gates across authoring, pack, QA, and distribution. Configuration is versioned, approvals are recorded with audit trails, and cross‑module interlocks are testable.

V5 QMS. In the V5 QMS, TGO‑driven text, storage statements, and warnings live under Document Control. Changes auto‑spawn tasks for artwork updates, training, and internal audits. Nonconformances route through CAPA with effectiveness checks.

V5 MES. The V5 MES pushes the current label variables to printers, verifies barcodes/UDI, and applies hard gates if the wrong version or storage wording is detected. The eBMR links proof of verification to each lot.

V5 WMS. The V5 WMS enforces printed storage statements via location rules, Directed Picking, and FEFO. Cases and pallets are closed with GS1‑128/SSCC and published via EPCIS. If storage or label mismatches arise, stock is auto‑quarantined and a Deviation opens.

Bottom line: V5 operationalizes TGOs—governed wording, verified printing, gated execution, and traceable shipping work as one evidence chain.

18) FAQ

Q1. Do TGOs apply to both medicines and devices?
Yes—TGOs cover different categories and topics (e.g., labels, quality expectations). Map applicability by SKU and product type, and harmonize with device UDI and global expectations where relevant.

Q2. How do we prevent outdated labels from being used?
Centralize Labeling Control, feed governed variables to printers, and enforce hard gates in MES that reject any print or pack with non‑current versions.

Q3. What evidence proves TGO label compliance on a batch?
The batch should show variable values used, template version, pre‑flight/line clearance, pass/fail scans (and vision images if used), CoA, and QA disposition—captured in the eBMR with audit trails.

Q4. How do storage statements flow into warehousing?
Translate printed statements into WMS rules (zones, bin logic, FEFO). Validate with temperature mapping and enforce via Directed Picking.

Q5. How should we manage partners who print packaging off‑site?
Use governed file distribution and on‑press verification, qualify through VQ, audit with LPA, and enforce corrections with SCAR.

Q6. What ties TGOs to our broader QMS?
TGOs sit inside your QMS via Document Control, approvals, internal audits, APR/PQR, and CAPA. The label is just the output; the system makes it reliable.

Related Reading
• Labeling & Identity: Labeling Control | Label Verification | Machine Vision | GS1 GTIN | GS1‑128 Case Label | SSCC | UDI
• QA/QC & Release: QC & Release Evidence | CoA | Lot Release | Hold/Release | TMV | Process Validation | PPQ
• Stability & Distribution: Stability Studies | Temperature Mapping | GDP | WMS | FEFO
• Governance & Records: QMSR | Document Control | Approval Workflow | Internal Audit | Data Integrity (ALCOA+) | Audit Trail | Record Retention | CSV | GAMP 5
• Execution & Shipping: Pack & Ship | ASN | Manifest | Bill of Lading | EPCIS | EDI