Therapeutic Goods Administration (TGA) – Australia Regulator

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

Updated October 2025 • Market Authorization, GMP/GDP & Device Compliance • QA/RA, Manufacturing, Supply Chain, IT/OT

The Therapeutic Goods Administration (TGA) is Australia’s national regulator for medicines, medical devices, and other therapeutic products. In practice, TGA oversight touches every function in a compliant operation: from supplier controls and Vendor Qualification, to GMP manufacturing with governed Quality Management Systems (QMS), to device UDI and the Australian UDI/AusUDID pathway (Device UDI in Australia). The regulator expects not only compliant dossiers and labelling, but also day‑to‑day process control evidenced by tamper‑proof records (audit trails), disciplined Change Control, and proven release decisions (Lot Release) across your integrated MES, WMS, and lab systems.

“Regulatory compliance is not a promise in a dossier; it’s a system of controls that makes the wrong action physically impossible.”

1) Scope—What TGA Oversees (and What It Doesn’t)

Oversees: the evaluation and ongoing regulation of medicines, medical devices, some biologicals, and related therapeutic goods. This includes product registration/market authorization, GMP licensing and inspection of manufacturers, device conformity to a certified ISO 13485 QMS, labelling and packaging controls, UDI/AusUDID data publication (Australia UDI), and post‑market vigilance/recalls.

Does not: write your SOPs or operate your lines. That’s your QMS, translated into plant reality through SOPs, role‑based training, in‑process controls, and validated digital interlocks (hard gating) in MES/WMS.

2) Sponsors, Manufacturers & Distributors—Who Owns What

Australian market access typically flows through a sponsor of record (often the local legal entity) who is responsible for product registration, labelling compliance, and post‑market actions. Manufacturers must sustain a compliant GMP state, governed by a documented QMS with robust Document Control, MOC/Change Control, Internal Audit, and supplier oversight (VQ, SQM, SCAR). Distributors and logistics partners operate under GDP, with temperature, segregation, and traceability controls enforced by WMS.

Strong quality agreements between sponsor, CMO, and distributors clarify who does what—especially for stability, complaints, recalls, and regulatory correspondence.

3) Registration & Dossier Expectations—Quality Evidence First

Market authorization relies on complete, controlled evidence: quality (manufacturing process, specifications, validation, stability), safety/clinical (as applicable), and compliant labelling/packaging governed by Labeling Control. Device submissions rest on ISO 13485 QMS conformity, ISO 14971 risk management, labelling/UDI (AusUDID), and post‑market plans tied to CAPA.

For trans‑Tasman portfolios, align differences between Australian and New Zealand product information. Our overview of NZ requirements (NZ Data Sheet & CMI) helps teams avoid copy‑paste errors in claims, statements, and formatting.

4) GMP in Australia—Inspections, Licences & Evidence

TGA inspects manufacturers for sustained GMP compliance. Be inspection‑ready through lifecycle process validation (PPQ → CPV), facility/utility IQ/OQ/PQ, and a controlled MBR/eBMR with IPC, SPC, and Cleaning Validation. Labs must be competent and traceable; align to ISO/IEC 17025 expectations for methods and calibration where applicable.

Before every run, verify Line Clearance, ensure accurate labels (Label Verification), and maintain Environmental Monitoring. Release only after QA review and disposition, with records that stand up to scrutiny without rework.

5) Labelling & Packaging—Controls That Print What You Prove

Australian labelling has jurisdiction‑specific content and format expectations. Treat labels as controlled documents under Labeling Control; drive variables from governed masters (GS1 GTIN, batch/expiry). Verify prints with scanners or vision (Label Verification), and aggregate units into cases/pallets using GS1‑128 case labels and SSCC for logistics identity. If labels can print when QA status is not released, you don’t have control—only ink.

6) UDI & AusUDID—Device Identity in Australia

Australia’s UDI regime requires standardized device identification and data publication. Build UDI at the master‑data level (UDI), align device risk files to ISO 14971, and orchestrate submissions per the AusUDID transition. For global portfolios, maintain clean mapping across markets (e.g., US UDI concepts) while avoiding label drift through Document Control and Approval Workflows.

Downstream, tie UDI to case/pallet identities (SSCC) and publish shipping events (EPCIS) so recall scopes can be executed in minutes, not days.

7) Post‑Market Surveillance—From Signal to CAPA

Post‑market expectations include complaint handling, defect/recall decisions, and ongoing quality trending. Operationalize with integrated Deviations/NCR, RCA, and effective CAPA; connect lab signals (OOS, OOT) to batch and distribution records. Summarize trends annually in APR/PQR and monitor shelf‑life via stability studies and storage verification (temperature mapping).

When a recall is necessary, execution speed is everything. Use end‑to‑end genealogy, EPCIS events, and Pack & Ship evidence to prepare lists of affected customers within hours (Recall Readiness).

8) GDP & Distribution Integrity—Warehouse Truth Matters

Distribution risks (temperature excursions, mix‑ups, market mismatches) are controlled by a disciplined WMS: Directed Put‑Away to segregated zones (Quarantine/Hold), FEFO/FIFO picking (FEFO/FIFO) driven by Directed Picking, and scan‑based gating to prevent shipment of unreleased stock. Exchange ASNs, reconcile to the Bill of Lading (BOL) and Shipping Manifest, and keep a defensible trail from dock to consignee.

For device portfolios with UDI, pair unit identity to logistics units (SSCC) and publish movements via EPCIS for transparent custody transfer.

9) Computer Systems & Data Integrity—How You Prove It

TGA expects trustworthy electronic records. Operate under Part 11/Annex 11-style controls with GAMP 5 risk‑based CSV, unique credentials, meaningful e‑signatures, time sync, and immutable audit trails. Keep configurations under Document Control and records preserved per Record Retention & Archival rules.

Integrated devices (balances, checkweighers, printers, vision) require qualification (IQ/OQ/PQ) and continual status checks (Calibration Status).

10) Risk Management, Safety & Process Control

For devices, risk is structured by ISO 14971; for processes, design quality in via QbD, model hazards with PFMEA, and deploy a living control plan. Demonstrate control through SPC and capability (Cp/Cpk). Where applicable, align to sector‑specific frameworks like HACCP for complementary health products or ingredients.

All of this rolls up into your site’s risk register and QRM—the core of defendable decisions under inspection.

11) Inspection Readiness—Evidence on Demand

Keep an always‑ready pack: org charts and responsibilities; Training Matrix and records; facility/equipment states (IQ/OQ/PQ, maintenance); VMP and CSV traceability; recent internal audits and CAPA effectiveness; example eBMRs with audit‑trail extracts; distribution evidence from pick to BOL. Demonstrate live interlocks—e.g., Hold/Release blocking in WMS and MES.

During close‑outs, link findings to RCA and provide measurable CAPA commitments with due dates and owners.

12) Metrics That Prove Control

• Right‑First‑Time / FPY and OEE across key product families.
• Deviation density & time‑to‑closure; CAPA effectiveness and recurrence rates.
• Release lead time (batch complete → QA disposition), with OTIF at shipment.
• Traceability readiness: time to list all recipients for any lot/UDI (EPCIS match rate).
• Data integrity: audit‑trail review completion, blocked unauthorized changes (UAM).
• Supplier quality: COA defect rate, incoming‑inspection failure rate, SCAR closure time.

Use these KPIs in management review and feed improvements into Kaizen, Lean, and TPM programs.

13) Common Failure Patterns (and Antidotes)

• Shadow systems. Spreadsheets for batch, label, or UDI data. Antidote: migrate to controlled eBMR and label templates with verification; centralize UDI masters.
• Status bypass. Moving unreleased/quarantined goods. Antidote: enforce hard gating in WMS/MES and auto‑raise NCRs for attempted overrides.
• Label drift across markets. Reusing claims/artwork without control. Antidote: jurisdiction‑specific Labeling Control and approvals; validate barcodes and UDI layout via on‑line checks.
• Weak CSV. No audit trails, shared logins. Antidote: risk‑based CSV, UAM, and routine log reviews.
• Supplier blind spots. No structured VQ or SCAR loop. Antidote: formalize qualification, monitoring, and escalation.
• Recall friction. Incomplete genealogy. Antidote: publish EPCIS events and maintain parent‑child aggregation (SSCC).

14) How This Fits with V5 by SG Systems Global

V5 QMS. The V5 QMS governs documents, training, deviations, CAPA, MOC, and supplier quality with attributable evidence and e‑signatures aligned to data integrity.

V5 MES. The V5 MES executes controlled MBRs to eBMR, integrates devices, applies hard gates, and streams SPC for provable process control.

V5 WMS & Labeling. The V5 WMS enforces FEFO/FIFO, Directed Picking, and Hold/Release. The label engine is governed under Labeling Control with on‑line verification and supports UDI barcodes used in the AusUDID transition.

Bottom line: V5 unifies QMS, MES, WMS, and labelling so TGA compliance becomes a by‑product of how you work, not an after‑the‑fact exercise.

15) FAQ

Q1. Is the TGA the same as New Zealand’s regulator?
No. Australia’s TGA regulates the Australian market; New Zealand’s regulator is separate. If you market in NZ, align with their product information expectations (NZ Data Sheet & CMI) in addition to Australian labelling.

Q2. What GMP standard does TGA expect?
TGA inspects against internationally aligned cGMP principles. Practically, keep complete validation/qualification evidence, controlled batch records (eBMR), and robust data integrity controls (audit trails).

Q3. How does AusUDID change device labelling work?
You must generate and maintain standard device identifiers and submit required data; align your label templates and barcodes with UDI rules and the AusUDID transition.

Q4. Do we need validated computer systems for TGA?
Yes—where records support GxP decisions. Apply risk‑based CSV per GAMP 5 and operate under Part 11/Annex 11 expectations for signatures and audit trails.

Q5. What’s the fastest way to prove distribution integrity?
Show FEFO/FIFO enforcement, blocked shipment of unreleased stock (Hold/Release), UDI linkage to SSCC, and EPCIS shipment events reconciled to the BOL/manifest.

Related Reading
• Core Quality & Governance: QMS | Policies | Document Control | Internal Audit | APR/PQR
• Manufacturing & Labs: GMP | Process Validation | eBMR | IPC | SPC | ISO/IEC 17025
• Devices & Risk: ISO 13485 | ISO 14971 | UDI | AusUDID
• Labelling & Traceability: Labeling Control | Label Verification | GS1-128 Case Label | SSCC | EPCIS
• Distribution & Logistics: GDP | WMS | Directed Put‑Away | Directed Picking | Pack & Ship