Good manufacturing practice in Australia for medicine makers
Good manufacturing practice controls medicine quality. In Australia, check TGA or APVMA requirements against the site, products and manufacturing steps.
Good manufacturing practice in Australia
Good manufacturing practice (GMP) means controls over premises, equipment, people, manufacturing work, and records that protect medicine quality. In Australia, human therapeutic goods follow the TGA framework in the Therapeutic Goods Act, while veterinary chemical products follow the separate APVMA framework in the Agvet Regulations.
But a company name, or a claim to be "GMP certified", isn't enough. Check the premises, the goods and the manufacturing steps against the relevant authorisation. Then read its conditions.
What GMP means in practice
GMP stands for good manufacturing practice, and the plural good manufacturing practices means the same controls. Section 36 of the Therapeutic Goods Act allows manufacturing principles for therapeutic goods for use in humans. They can cover premises and equipment, quality assurance and quality control, staff qualifications and experience, and manufacturing practices. They can also include GMP codes.
That gives a quality team more to examine than the finished product. The premises, staff and controls used to make it also matter. For a pharmaceutical supplier assessment, ask for evidence of the work the supplier will perform. A general statement about the business is not that evidence.
The veterinary requirements give concrete examples. Regulation 61 of the Agvet Regulations supports checks on:
- traceable materials and supplier records
- documented production controls and product testing
- identifiable batches
- complaint and product-failure records
- audit follow-up
Use these as starting points for questions, not as a complete audit checklist. Ask how a batch can be traced through materials, production and testing. Request the records that support the answer.
A certificate alone will not answer those questions.
APVMA and TGA requirements are different
Choose the regulatory framework before reviewing a supplier's documents. A human-medicine GMP reference should not be treated as the universal Australian standard for veterinary manufacture.
| Check | Human therapeutic goods | Veterinary chemical products |
|---|---|---|
| Relevant regulator | TGA | APVMA |
| Legal foundation discussed here | Therapeutic Goods Act, Part 3-3 | Agvet Regulations |
| GMP source | Manufacturing principles instrument adopting a specified PIC/S Guide with Australian qualifications | Manufacturing principles and the Australian veterinary GMP Code identified in the regulations |
| Supplier-review focus | Specified premises, goods and manufacturing steps | Relevant site, product category and authorised activities |
The human-medicine framework comes from the Therapeutic Goods Act and the Manufacturing Principles Determination. The separate veterinary-code requirement appears in regulations 3 and 61 of the Agvet Regulations.
For human therapeutic goods, separate publication of a PIC/S Guide from its adoption in Australia. The determination adopts a specified guide, with Australian qualifications on how that guide applies. Calling the requirement current good manufacturing practices does not let you skip that instrument. Don't treat the newest PIC/S publication as the Australian requirement until you check the instrument and later amendments.
For veterinary chemical products, use the manufacturing principles and the veterinary GMP Code identified in the Agvet Regulations. A human-medicine guide does not establish that separate requirement.
What does GMP certified mean?
Treat "GMP certified" as a prompt to request the document. The phrase alone leaves the regulator, premises, covered products and activities unclear. For Australian human therapeutic goods, section 38 links licensing to specified manufacturing steps, goods and premises under the Therapeutic Goods Act.
Ask the supplier which document supports its claim. Compare the document with the work you intend to buy. A document covering one address or activity does not, by itself, answer a question about another address or activity.
Record what you checked. Keep the document reference, the premises and the covered work together in the supplier assessment. If the supplier provides a broad marketing statement instead of the authorisation, ask for the underlying evidence before closing that assessment.
GMP certification also doesn't settle every future compliance question. Section 40(4) of the Therapeutic Goods Act sets default licence conditions unless the licence says otherwise. They include applicable standards, the manufacturing principles, reporting of relevant quality, safety or efficacy information, and access for inspection, samples and documents. Read the actual conditions. A licence is not a substitute for ongoing compliance.
How to check a manufacturer
These checks organise a document review. They are not a full licensing assessment. Read the applicable legislation and regulator guidance before you rely on them for an operational decision.
Choose the regulator and document
Start with the product and the proposed manufacturing work. For human therapeutic goods, use the TGA licensed-manufacturer entry point or TGA business-services databases. For veterinary chemical manufacture, start with APVMA manufacturing information.
Use those pages to find the relevant regulatory information. Obtain the supplier's authorisation too. A directory search and a supplier's document should be assessed together, rather than treating either as a complete answer on its own.
Match the legal holder and premises
Compare the legal holder with the supplier you intend to qualify. Then compare the site address with the place where your work will happen. Don't stop at a familiar trading name.
On the TGA side, the Act's licensing provisions expressly link the licence to premises and manufacturing steps. If the address does not match, ask the supplier to explain the difference and provide evidence for the proposed site.
Match the goods and manufacturing steps
Write down the work you are assessing before comparing it with the document. Check the goods or product category and each relevant manufacturing activity. Avoid recording only "GMP approved" in the supplier file.
For veterinary manufacture, use APVMA's manufacturing entry point to find the relevant licence information. Obtain the current authorisation and check its scope and conditions. For human therapeutic goods, compare the proposed work with the goods and steps covered under the Act's licensing framework.
Read conditions and establish current status
Ask for evidence that the authorisation applies to the proposed work now. Read any conditions that affect your assessment. If the evidence is unclear, keep that question open rather than filling the gap with a general GMP claim.
For an overseas site, check the relevant regulator's overseas evidence route. Don't assume an Australian domestic manufacturing licence is the correct document. Establish which evidence route applies before judging whether the supplier's paperwork is sufficient.
Investigate a missing entry
A missing manufacturer-list entry is a reason to investigate, not proof of unlawful operation. Human-therapeutic-goods licensing has exemptions under the Therapeutic Goods Act. Veterinary exclusions and conditional exemptions appear in regulations 59 and 59A of the Agvet Regulations.
Ask the supplier to identify the basis it relies on. Check the qualifying conditions against the actual product and activity. Don't accept a broad exemption label without that match, or infer an exemption merely because the business performs only one manufacturing step.
For a regulatory starting point, RegAffairs AI answers this Australian GMP question with citations to its stored regulatory sources. Check the applicable legislation and amendments before relying on an older compilation for a supplier decision.