GMP Certification in Australia: What It Actually Means When You're Choosing a Cosmetic Manufacturer

Most founders never think about manufacturing standards until somebody else forces them to, and by the time that happens there is usually a deadline attached.

The pattern is almost always the same. A brand gets some traction, a retailer or a distributor or an export agent comes back with a supplier pack, and somewhere in the middle of it sits a question that has never come up before, asking who manufactures the product and to what standard. Sometimes it is a single line requesting a GMP certificate and sometimes it runs to three pages of quality questions, but either way the founder is now being asked about a facility they have never audited, in a vocabulary they have never needed, with an order sitting on the other side of the answer.

We went through ISO 22716 certification ourselves, so what follows is written from inside the process rather than as a summary of the standard, and it is deliberately practical rather than complete. Whether you end up working with us or with somebody else, you should leave this able to answer that question properly and to tell the difference between a manufacturer who can back up the claim and one who is hoping nobody checks.

What GMP actually means, and where ISO 22716 fits

GMP stands for Good Manufacturing Practice, and it is less a rulebook than a principle that runs across food, pharmaceuticals, supplements and cosmetics alike, which is that a product should be made the same way to the same quality every single time and that you should be able to prove afterwards that it was.

The proving is the part people miss. Being clean and careful is not GMP, because plenty of manufacturers are clean and careful and always have been. GMP is being clean and careful in a way that leaves a documented trail behind it, so that six months after a batch has shipped and a complaint arrives from a customer nobody has ever met, somebody can sit down and reconstruct exactly what went into that batch, who made it, what it was checked against and where the rest of it went.

For cosmetics the standard that defines what that looks like in practice is ISO 22716, published by the International Organization for Standardization as Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. It runs to seventeen clauses covering personnel, premises, equipment, raw and packaging materials, production, finished products, the quality control laboratory, the treatment of product that falls out of specification, wastes, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation. Read as a list it sounds like paperwork, and a fair amount of it is, but the underlying logic is that every one of those seventeen areas is somewhere a product can quietly go wrong without anybody noticing until it is on a shelf.

When somebody asks whether your manufacturer is GMP certified for a cosmetic product, ISO 22716 is almost always the standard they mean even when they do not say so.

Is GMP certification mandatory in Australia?

No, and this is probably the most useful thing in this article, so it is worth being blunt about it rather than burying it.

Australian law does not require a cosmetic manufacturer to hold GMP certification. Cosmetic ingredients are regulated at the chemical level through AICIS, which treats them as industrial chemicals regardless of whether they are described as natural or organic, labelling obligations sit under Australian Consumer Law, and therapeutic goods are a separate and far heavier regime administered by the TGA. None of those impose a manufacturing standard on a cosmetics facility, and there is no cosmetic manufacturing licence in Australia the way there is for medicines. If the boundaries between AICIS, the TGA and the ACCC are still fuzzy, we have written that one up separately.

So GMP certification in Australian cosmetics is voluntary, which means the real question was never a legal one at all. Nobody is going to fine you for using an uncertified manufacturer. What happens instead is that doors close quietly and usually at the worst possible moment, because the people who ask about manufacturing standards tend to be the people who are about to give you a lot of volume.

Retailers ask, particularly the larger chains and pharmacy groups, and they ask during supplier onboarding rather than after. Export markets ask, and the European Union goes considerably further than asking, because Article 8 of Regulation (EC) No 1223/2009 requires cosmetic products placed on the EU market to be manufactured in compliance with good manufacturing practice, with ISO 22716 published as a harmonised standard that gives a presumption of conformity. Distributors ask before they will carry the risk of your product, insurers and legal counsel ask when product liability is being priced, and third-party logistics providers occasionally ask before they will hold your stock. None of those are laws. All of them are gates, and they tend to appear at exactly the moment you are trying to scale.

Do I need to be GMP certified, or does my manufacturer?

This is the question founders actually want answered and the one almost nobody addresses properly, so here it is plainly, your manufacturer holds the certificate and you hold the evidence.

If you are a brand owner without your own facility, which describes nearly every founder we work with, there is nothing about your business that can meaningfully be certified. Certification is an assessment of a physical site, its systems, its people and its records, and you do not have a site. What you have instead is a position in a supply chain, where your product is made somewhere that has been independently assessed and you can produce the documents that prove it, and that is what a retailer's compliance team is really evaluating when the question lands. They are not assessing you. They are assessing the chain behind your product and whether anybody in it can be held accountable if something goes wrong.

In practice that means you should either hold, or be able to obtain within a day, a copy of your manufacturer's current certificate showing the certificate ID, the standard, the scope and the expiry date, along with confirmation that your product category actually falls inside that scope, batch documentation for the runs of your product, and a manufacturer willing to answer a quality questionnaire directly rather than making you play messenger. If those things take a week to appear, that is information in itself.

The scope line deserves particular attention, because it is the most common way a GMP claim falls apart under scrutiny. Every certificate states what it covers and ours says manufacture of personal care products, but a certificate whose scope reads packing and labelling only is a perfectly genuine certificate that does not cover manufacturing at all, and a certificate covering a product category that is not yours does not cover your product. Read the scope line every time, because a buyer's compliance team certainly will, and when founders ask whether they need to become a GMP certified cosmetic manufacturer themselves the honest answer is that they need to be supplied by one and hold the paperwork that proves it.

What a retailer is actually asking for

Usually much less than founders fear and something considerably more specific than a certificate, because everything in a supplier pack is downstream of a single question, which is whether there is a chain of accountability behind this product and whether it can move quickly if the product has to come off a shelf.

What they generally want is the certificate itself, current and in date with a legible ID and a scope they can read, and many compliance teams will verify it with the certification body rather than taking the PDF at face value. Beyond that they want traceability, meaning the ability to take a finished unit off a shelf, identify the batch it came from and identify the specific supplier lot of every raw material that went into that batch, which is the single most important capability in a recall and the place where uncontrolled operations most often come apart, not through carelessness but because reconstructing that chain after the fact is close to impossible if nobody was recording it at the time. They want batch records showing what went in, in what quantity, from which lot, made by whom and checked against which approved formula. They want retention samples, meaning a kept sample of each batch stored properly, so that a complaint arriving eight months later can be tested against something physical rather than argued about. They want a recall procedure, and the sharper buyers will ask whether it has ever actually been run rather than merely written. And they want evidence that when something does not go to plan it gets recorded and investigated rather than quietly corrected.

If you are assembling a supplier pack now, ask your manufacturer for those six things by name. Every one of them falls inside the seventeen clauses of ISO 22716, which is why a certified manufacturer will generally have them sitting ready rather than needing to go and build them.

ISO 22716, ISO 9001 and pharmaceutical GMP are three different things

They sound similar enough that they get used interchangeably, and the difference matters when you are comparing manufacturers.

The practical consequence is that ISO 9001 is not a substitute for ISO 22716 when the product is a cosmetic, because a manufacturer holding only ISO 9001 has demonstrated that they manage quality as a business rather than that they manufacture cosmetics to cosmetic GMP. Some hold both, some hold neither, and some describe themselves as GMP compliant without a certificate behind the phrase, which is worth pausing on. Anybody can say they follow good manufacturing practice, and many manufacturers who say it are telling the truth, but certification means an independent body sent an auditor, examined the system and the records against the standard and issued a certificate with an ID on it that can be checked. If a manufacturer describes themselves as GMP compliant, the reasonable next question is simply who certified them and what the certificate number is.

What changes on the floor

It is worth being honest about this rather than treating certification as a logo, because the audit is not the hard part and never was.

Building the documented system is the hard part, and living inside it afterwards is harder still. Every batch now carries a manufacturing record, which is not a note but a controlled document recording what was made, from which raw material lots, by whom, checked by whom, against an approved formula and with actual quantities captured as they were used rather than reconstructed later. Every raw material traces back to a supplier lot and an expiry date, which means that when a supplier flags a problem with a lot we can identify every batch it entered and every client affected in minutes instead of days. Equipment is calibrated and maintained against a schedule and the schedule is evidenced, cleaning between products is logged so that cross-contamination between one client's formula and the next is a matter of record rather than a matter of trust, and retention samples are held for every batch so that a complaint months later has something physical to test against.

The culturally difficult one is deviations. When something does not go exactly to plan the instinct in any small operation is to fix it and move on, and under GMP it gets written down, investigated and closed out even when the fix was obvious and the outcome was fine. That habit takes months to build and it is the part a certificate on a wall communicates least well.

Our team runs formulation and production against those systems, and the shortest honest summary of what changed for us is that the record of every batch now matters as much as the batch itself. That is the part worth understanding when you are choosing a manufacturer, because certification is not a claim about how good the products are, it is a claim about how controlled the process is, and process control is what makes a good product repeatable at volume, which is the only thing that matters once somebody is buying it in thousands.

What GMP certification does not mean

This matters as much as the rest and is rarely said out loud by anybody with a certificate to wave around.

It does not mean the formula is good, because GMP governs how a product is made rather than whether it was well designed, and a poorly formulated product manufactured under perfect GMP is simply a consistently poor product. It does not make your claims legal, since marketing claims are governed by Australian Consumer Law and by the TGA the moment you drift into therapeutic territory, and no certificate has any bearing on whether you can say your serum repairs anything. It is not a safety assessment of your product either, because stability, compatibility, preservative efficacy and safety substantiation are separate pieces of work that have to be done regardless. It does not cover your packaging or your labelling, which remain your obligations as the brand owner. And it does not cover anything outside the scope printed on the certificate, which brings us back to reading the scope line.

Anybody selling GMP certification to you as a guarantee of product quality is overselling it considerably. It is a floor rather than a ceiling, but it is a floor that a surprising number of operations do not meet.

Where Labwork fits in

We are a cosmetic formulation and contract manufacturer in Australia, working out of a facility on the Sunshine Coast in Queensland, and we formulate and manufacture liquid hair, skin, body and pet care products for Australian and international brands.

Labwork is a GMP certified cosmetic manufacturer, certified to ISO 22716:2007 Good Manufacturing Practices and independently assessed and certified by ECAAS Certification International.

We publish the certificate ID because a certificate nobody can verify is not worth very much, and if you are building a supplier pack and need the certificate itself, written confirmation of the scope, or answers to a retailer's quality questionnaire.

None of this replaces how we already worked so much as it puts a frame around it. Our formulation philosophies remain the same, which is about being better for you, better for your skin and better for the planet without pretending that means everything has to be natural or accepting that it has to come at the cost of performance. But better for you is only worth saying if the process behind it is controlled, because a thoughtful formula made in an uncontrolled facility is a thoughtful formula you cannot reliably reproduce, and reproducibility is the whole game once you are supplying somebody at volume.

Frequently asked questions

What is GMP certification?

GMP certification is independent verification that a manufacturing facility has established, documented and implemented a Good Manufacturing Practice system meeting a defined standard, which for cosmetics is ISO 22716. A certification body audits the site, its systems and its records, then issues a certificate carrying an ID, a stated scope and an expiry date. It certifies how products are made and documented rather than the products themselves.

How do I get a GMP certificate in Australia?

You engage an independent certification body, implement a quality management system meeting the standard, and pass an audit. In practice it runs in stages, starting with building and documenting the system, then a pre assessment or Stage 1 review of that documentation, then a Stage 2 certification audit that examines the system in operation and the records it has generated. Certificates are issued for a defined period and are maintained through ongoing surveillance by the certification body. The documentation build is by far the longest part, and most of the real effort sits in establishing procedures and then operating against them long enough to produce records worth examining.

What is the GMP certificate for cosmetics?

For cosmetics the relevant standard is ISO 22716, the international GMP standard written specifically for cosmetic products. Its seventeen clauses cover personnel, premises, equipment, raw and packaging materials, production, finished products, the quality control laboratory, out-of-specification product, wastes, subcontracting, deviations, complaints and recalls, change control, internal audit and documentation. A GMP certificate held by a cosmetics manufacturer will normally cite ISO 22716 and state the scope of manufacturing it covers.

How much does a GMP certificate cost?

It varies widely with the size of the facility, the scope being certified and how much of the quality system already exists, and the certification body's audit fee is usually the smaller part of the total. The larger cost is internal, in building the documented system, training people to work inside it and running it long enough to generate the records an auditor needs to see. It is better budgeted as a project than as a purchase, and the first year is the heaviest.

What is the difference between ISO 9001 and ISO 22716?

ISO 9001 is a generic quality management standard applicable to any industry and says nothing specific about manufacturing cosmetics, while ISO 22716 is the cosmetics-specific Good Manufacturing Practice standard covering the production, control, storage and shipment of cosmetic products. A manufacturer can hold ISO 9001 without meeting cosmetic GMP, so if your product is a cosmetic then ISO 22716 is the one that speaks to how it is actually made.

Who needs a GMP certificate?

The manufacturer rather than the brand. If you are a brand owner without your own facility there is nothing to certify, because certification assesses a physical site, its systems and its records. What you need is a manufacturer holding a current certificate whose scope covers your product category, along with the documentation proving your product is made there, and that is what retailers, distributors and export markets are actually checking.

Do you need a licence to sell cosmetics in Australia?

No licence is required to sell cosmetics in Australia, though there are obligations that apply regardless. Ingredients must comply with AICIS requirements, labelling must meet the mandatory standard under Australian Consumer Law, and your claims must remain cosmetic, because the moment they become therapeutic the product falls under the TGA and an entirely different regime applies. GMP certification is not among the legal requirements, which is precisely why it functions as a commercial one instead.

Is GMP certification required to sell into retailers?

Not legally, but increasingly in practice. Larger retailers, pharmacy groups, distributors and export markets commonly ask for evidence of manufacturing standards during supplier onboarding, and the European Union goes further still, since Article 8 of Regulation (EC) No 1223/2009 requires cosmetics placed on that market to be manufactured in compliance with GMP. If retail or export sits anywhere on your roadmap, it is worth knowing where your manufacturer stands before a buyer asks rather than afterwards.

This is general information rather than legal or regulatory advice. For specific situations, consult a regulatory consultant or the relevant authority (AICIS, TGA, or ACCC / Product Safety Australia).

Last updated: September 2026