TGA Release for Supply (RFS) – Batch Certification for the Australian Market

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

Updated December 2025 • TGA, TGO Standards, TGA GMP Clearance, Batch Release, Release Status, PQS, Data Integrity • Australian Sponsors, QP/Authorised Persons, QA, Regulatory, Supply Chain

TGA Release for Supply (RFS) is the formal decision, made on behalf of the Australian sponsor, that a specific batch of medicine or biological product complies with its marketing authorisation, relevant TGO standards and GMP requirements and may lawfully be supplied to the Australian market. It is the Australian analogue to EU “QP release” and US “batch disposition,” adapted to a system where the legal sponsor may sit in Australia while manufacture happens elsewhere. In day-to-day operations, RFS is the last gate between manufacturing and patients: it is where batch records, deviations, test results, GMP status and regulatory conditions are integrated into a single “yes/no” decision.

“Release for Supply is not just ticking a box; it’s the point where the sponsor says: ‘we stand behind this batch in front of the TGA and every hospital, pharmacy and patient in Australia.’”

1) What TGA Release for Supply (RFS) Actually Is

RFS is the sponsor’s formal decision that a particular batch is fit for supply in Australia, based on a documented review of all relevant information. It sits at the end of the GMP lifecycle: after manufacture, testing and QA review, but before product enters the Australian distribution chain. The RFS decision must ensure that the batch:

• Matches the details registered with TGA (strength, dosage form, composition, manufacturing sites, shelf life).
• Complies with all relevant Therapeutic Goods Orders (e.g. TGO 91/92 for labelling, specific product standards).
• Has been manufactured under acceptable GMP with up-to-date TGA GMP clearance where applicable.
• Has no unresolved critical quality issues, deviations or stability concerns.

RFS is usually executed by a designated “Authorised Person” within the sponsor’s or manufacturer’s QMS, but legal responsibility rests with the Australian sponsor and, ultimately, with the person who signs off.

2) Legal and Regulatory Context in Australia

Under the Therapeutic Goods Act and Regulations, medicines and biologicals supplied in Australia must be included in the ARTG and comply with relevant standards and GMP. TGA guidance describes “Release for Supply” as the batch certification step that confirms these obligations are met prior to supply. For locally manufactured products, this aligns closely with on-shore GMP controls. For imported products, RFS is the main mechanism by which the Australian sponsor takes responsibility for overseas manufacture: the sponsor must ensure the batch comes from sites with valid TGA GMP clearance and that batch documentation and testing demonstrate compliance with the registered product particulars and TGO standards.

3) How RFS Compares to EU QP Release and US Batch Disposition

Conceptually, RFS plays a similar role to EU QP release and US batch disposition, but the legal framing differs:

• EU: A named QP at a licensed site certifies each batch for the EU/EEA based on QP-specific obligations.
• USA: The quality unit approves or rejects each batch; responsibilities are defined in 21 CFR 211.
• Australia: The sponsor (or their delegated Authorised Person) certifies Release for Supply, with TGA expecting EU/WHO/PIC/S-level assurance that data and GMP are under control.

Practically, RFS must deliver the same level of assurance: that the batch being supplied is compliant and that the decision-maker has sufficient independence, authority and information. For companies running global networks, aligning RFS processes with EU QP-style thinking and US batch disposition experience helps remove duplication and inconsistency.

4) Who Is Responsible for RFS

The Australian sponsor is legally responsible for ensuring that RFS is performed appropriately, even if technical execution is delegated to a contract manufacturer or local QA team. Within the QMS, an Authorised Person (or similar role) is typically designated to perform RFS decisions. This person must:

• Have defined qualifications, experience and training in GMP and quality assessment.
• Be independent enough from commercial pressures to withhold RFS when necessary.
• Have access to complete batch and GMP information, not just a summary.

TGA expects sponsors to define RFS responsibilities clearly in site procedures and quality agreements, including how RFS interacts with overseas batch release decisions, QP certifications and local market-specific checks (e.g. labels and pack components for Australia).

5) Inputs to an RFS Decision – What Must Be Reviewed

A defendable RFS decision draws on several categories of information, typically including:

• Executed batch records and packaging records, with all steps documented and reviewed.
• In-process and finished product test results, including any re-tests, and verification that methods and specifications match the registered particulars and TGOs.
• Review and closure of deviations, non-conformances, OOS/OOT results and investigations linked to the batch.
• Verification of critical materials and suppliers, including API and key excipients.
• Confirmation of up-to-date TGA GMP clearance and regulatory status for all relevant manufacturing and testing sites.
• Assessment of stability data (ongoing and, where relevant, accelerated) to confirm that the product remains within shelf-life specifications.
• Any post-approval commitments or conditions specific to the batch or product (e.g. additional testing, restricted distribution).

In mature systems, much of this information is surfaced through electronic workflows, dashboards and exception-based review rather than manual dossier assembly, but the underlying logic is the same.

6) Overseas Manufacture and TGA GMP Clearance

For imported products, RFS must explicitly consider TGA GMP clearance status. This means:

• Confirming that each overseas manufacturing and testing site has a current TGA GMP clearance covering the relevant activities.
• Ensuring that the sites used match those listed in the ARTG entry and regulatory documentation.
• Reviewing any restrictions or conditions attached to GMP clearance and factoring them into RFS decisions.

If a site loses clearance, is under significant GMP concern, or changes its scope, the sponsor must reassess RFS eligibility and potentially hold product, update dossiers or change supply arrangements. RFS cannot be treated as routine if the GMP foundation is shifting underneath it.

7) Data Integrity and Electronic Records in RFS

TGA, like other regulators, expects RFS decisions to be based on trustworthy data. That includes:

• Validated MES/eBMR systems for batch documentation.
• Validated LIMS for test results and stability data.
• Controlled user access, roles and electronic signatures.
• Complete, reviewable audit trails for critical data elements.

If RFS relies on data that can be backdated, overwritten or selectively reported, the decision is inherently unsafe. TGA inspections may sample records underpinning RFS decisions and test whether the sponsor’s data integrity controls are adequate—particularly in hybrid (paper + electronic) environments or in networks with multiple CMOs and labs.

8) RFS for Biologicals, Vaccines and High-Risk Products

Biologicals, vaccines and other high-risk products often have additional RFS considerations: complex manufacturing, cold-chain requirements, potency testing, specific TGO references and sometimes lot release by TGA’s own laboratories. For these products, RFS may need to incorporate:

• Verification that TGA official lot release (where applicable) has been completed and accepted.
• Review of additional stability or in-use studies in Australian conditions.
• Assessment of process performance and CPV data for critical quality attributes.
• Closer scrutiny of transport and storage conditions up to the point of RFS, especially for temperature-sensitive products.

RFS for such products is less about a checklist and more about confirming that a set of interdependent, risk-based controls are working as a coherent whole.

9) Release Status, ERP/WMS and Distribution Control

Within the QMS and business systems, RFS should be reflected in clear inventory status control: batches on “quarantine/hold” cannot be picked or shipped; batches “released for supply” can enter the Australian distribution chain. That means synchronising status between QA systems, ERP, WMS and logistics partners. Misaligned statuses—where ERP shows “saleable” but QA has not granted RFS, or vice versa—are a common cause of inspection findings and, in worst cases, illegal supply. Robust workflows and hard gating (no shipment without RFS status) reduce that risk and make audits much easier to defend.

10) Handling Deviations, Exceptions and Conditional RFS

RFS sometimes has to be decided in the presence of non-critical deviations or justified exceptions. A mature PQS will:

• Ensure that all deviations affecting the batch are documented, investigated and classified.
• Use risk assessments to determine whether residual risk is acceptable for supply.
• Document any additional testing or mitigation performed before RFS.
• Record the rationale for accepting residual risk, including sign-off by appropriate QA and, where needed, sponsor management.

“Conditional” release for supply—where some outstanding information is expected but risk is judged low—must be tightly controlled, rare and justified. TGA is unlikely to accept a pattern where RFS is routinely granted while critical issues remain unresolved and documentation is weak.

11) Transfers, Repacking and Local Packaging Activities

Some products are manufactured overseas but packaged or repacked in Australia under GMP. In these cases, RFS must integrate:

• Overseas manufacturing and testing data.
• Australian packaging and labelling records (including TGO 91/92 compliance).
• Verification that any rework, relabelling or repackaging is authorised and validated.

Quality agreements should specify which party (overseas manufacturer vs Australian site vs sponsor) performs which QA checks and how RFS is coordinated. A batch should not be released for supply to Australia based solely on overseas release if local packaging activities have not been fully reviewed and signed off under the same RFS decision.

12) TGA Inspections – How RFS Is Tested

During inspections, TGA may:

• Review RFS SOPs, quality agreements and role definitions.
• Trace specific batches from manufacture to RFS to distribution and recall readiness.
• Compare ARTG details, TGO compliance and GMP clearance with what RFS reviewers actually see.
• Sample eBMR/LIMS records supporting RFS decisions and test data integrity controls.

Inspectors often select a small number of batches and ask: “Show us exactly why you considered this batch fit for supply to Australia.” The clarity, completeness and consistency of that story are a strong indicator of PQS maturity. Vague answers (“the overseas QA did that”) raise concerns about how seriously the sponsor takes its responsibilities.

13) Common RFS Pitfalls and Failure Modes

Recurring RFS weaknesses include:

• RFS based on incomplete documentation or summaries, without access to full batch records.
• No explicit linkage between RFS and up-to-date TGA GMP clearance.
• RFS performed before all deviations and OOS investigations are closed.
• Poor alignment between RFS decisions and ERP/WMS status, leading to premature shipments.
• Multiple RFS “approvers” without clear roles, training or documented authority.

These are all symptoms of a system where RFS is treated as a routine checkbox rather than as a high-consequence quality decision. They are also relatively easy to detect in audits and inspections, which is why TGA—and other NRAs—pay close attention to them.

14) Integrating RFS into Global Batch Release Workflows

Global companies often want a single core batch-release process that supports multiple jurisdictions, then layer local checks (like RFS) on top. A practical approach is to:

• Define a global batch release framework (covering GMP, PQS, DI) aligned with EU/US standards.
• Add Australia-specific checks: TGA GMP clearance verification, TGO-specific labelling and testing, ARTG alignment.
• Embed these into electronic workflows so RFS is simply the “Australia node” in a multi-region release map, not a separate manual process.
• Ensure that supporting data are accessible across affiliates while respecting privacy and security controls.

When done well, RFS becomes a natural extension of global release rather than a bespoke, high-maintenance process, improving both compliance and efficiency.

15) Implementation Roadmap – Making RFS a Strong, Digital Control Point

A sensible roadmap for strengthening RFS includes:

• Clarifying sponsor and site roles for RFS in SOPs and quality agreements.
• Implementing or upgrading eBMR, MES and LIMS so all critical data needed for RFS are available and reliable.
• Adding RFS-specific checklists and dashboards (GMP clearance status, deviations, critical quality attributes, stability) to support exception-based review.
• Hard-gating shipments to Australia on RFS status via ERP/WMS integrations.
• Training Authorised Persons and QA staff on RFS principles, TGA expectations and risk-based decision-making.

The objective is that, when TGA asks about any batch, you can show a clear, data-backed path from manufacturing and testing to RFS and distribution in a few clicks—not a frantic paper chase.

16) FAQ

Q1. Is RFS required for every batch supplied to Australia, including imports?
Yes. Every batch of medicine or biological supplied to the Australian market should undergo Release for Supply, whether manufactured locally or imported. The sponsor is responsible for ensuring an appropriate RFS decision is made and documented.

Q2. Can we rely solely on overseas QP release or US batch disposition for RFS?
No. Overseas release decisions are important evidence but do not replace Australia-specific checks such as TGA GMP clearance scope, TGO compliance and ARTG alignment. RFS must explicitly consider the Australian regulatory context.

Q3. Who is allowed to sign off RFS decisions?
The sponsor should designate appropriately trained and experienced personnel (often termed Authorised Persons) within its QMS to perform RFS. While the exact title may vary, TGA expects these individuals to have clear authority, independence and access to information.

Q4. What happens if we discover a serious quality issue after RFS?
The sponsor must initiate investigation, risk assessment and, where needed, recalls or supply holds, and notify TGA according to applicable guidelines. The RFS process and underlying controls will likely be scrutinised during subsequent inspections and reviews.

Q5. What is a practical first step to strengthen our RFS process?
Map your current RFS workflow end-to-end for one product, identify which data are used (and which are missing), check alignment with TGA GMP clearance and ARTG/TGO requirements, and then upgrade SOPs, digital tools and training so that every RFS decision is fully evidence-based and traceable.

Related Reading
• Australia & NZ: TGA | TGO Standards | TGA GMP Clearance for Overseas Manufacturers | New Zealand Data Sheet & CMI
• Batch & Release: Batch Release | Release Status / QA Disposition | Recall Readiness
• PQS & Data: Pharmaceutical Quality System (QMS) | Quality Risk Management (QRM) | PQR/APR | Data Integrity | Audit Trail
• Systems & Traceability: Electronic Batch Record (eBMR) | MES | LIMS | WMS