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Role of the TGA Laboratories

11 August 2021

Duration: 
7 minutes

In this episode, we take a peek behind the curtains of the TGA laboratories with Dr Lisa Kerr, Assistant Secretary of the Laboratories Branch at TGA and Lucan Baillie, Director of the Biomaterials and Engineering section in the Laboratories Branch at TGA to discuss:

  • the history of the TGA labs and what actually happens there
  • what and how we test therapeutic goods
  • the current face mask testing program
  • tips for sponsors providing samples to TGA for testing

Host: Dr Jayne Foster

Guests: Dr Lisa Kerr and Lucan Baillie


Welcome to the Therapeutic Goods Administration's podcast series, SME Assist - Navigating therapeutic goods regulation. We appreciate that the regulation of therapeutic goods can be challenging to understand. Throughout this series, we aim to help small to medium enterprises, researchers, start-ups and anyone new or unfamiliar with regulation to understand their obligations when it comes to supplying therapeutic goods in Australia.

Please note that the information provided to you throughout these podcasts is without prejudice. It is not binding on the TGA, and you should get your own independent legal advice to ensure that all of the legislative requirements are met.

Dr Jayne Foster

Hi, I'm Jayne Foster from the SME Assist team at the Therapeutic Goods Administration. Welcome to our series of podcasts about navigating therapeutic goods regulation in Australia. If you haven't already, please be sure to hit subscribe and listen to our previous episode where we discuss supplying certain therapeutic goods for COVID-19.

Today we’re going to be talking about the role of TGA's Laboratories including when a product might require testing, how this is done and the current facemask testing that is being undertaken. Joining us today is Dr Lisa Kerr, Assistant Secretary of the Laboratories Branch, and Lucan Baillie, the Director of the Biomaterials and Engineering Section in the Laboratories Branch. Lisa and Lucan, welcome. It’s great to have you both here today.

Dr Lisa Kerr

Thanks, Jayne.

Lucan Baillie

Thanks, Jayne.

Dr Jayne Foster

We're really interested to hear about what happens in the TGA Laboratories. Please enlighten us.

Dr Lisa Kerr

So, many people think that we do efficacy testing in the laboratories. And actually what we do is quality testing. So, obviously, quality testing is very much related to the efficacy of the product, but basically the tests that we do are designed around looking at the, the quality of the products. So, testing is our core business, but we do more than just that.

So, for example, we perform some pre-market evaluations. So, in particular, for vaccines and other types of issues. So, for example, the laboratory staff evaluated the quality of the recent COVID vaccines that were announced by the Health Minister, as well as the stability of different products. And we also do, biocompatibility, assessments of containers. So, for example, our staff did the evaluation of the suitability of the vials used for the COVID vaccines.

Other things that we do are develop some of the standards that are used to test medicines and medical devices. So, in some cases, we might provide, practical input into what, a standard might look like. Or we provide expert advice into the format and, ultimate drafting of a, a standard for a therapeutic good.

We also discovered, through the pandemic, that one of the most important things that we do is provide expert advice to our government and to overseas government on the, the quality of therapeutic goods.

Dr Jayne Foster

Can you tell us a bit more about TGA's testing programme?

Dr Lisa Kerr

Sure. So, the TGA Laboratories have been around for a really long time. A lot of people don’t know that. So our engineering laboratory, for example, can trace its origins back to 1947. And other parts of the laboratories were opened in 1959. So, we’ve been around for a very long time. And we have a very diverse range of experts in the labs. So, for example, we have microbiologists, vaccine scientists, biochemists, chemists, molecular biologists and engineers and we usually test around 2,000 samples per year. But I suspect that that might have blown out in the pandemic, and we have done a lot more work than usual.

Dr Jayne Foster

So, what do we actually test here in the labs?

Dr Lisa Kerr

So, we test pretty much across the full range of products available in Australia. So, for example across those categories, we include prescription medicines, over-the-counter medicines, complementary medicines and medical devices, as well as products that have not been supplied legally in Australia. So, for example, the ones that are not registered on the Australian Register of Therapeutic Goods.

I think I would say at this point, too, that we pay an awful lot of attention to vaccines. So, we test the quality of products. A lot of people think that we are testing the efficacy. Quality and efficacy are very closely linked, but it’s the quality that we pay attention to in the Laboratories Branch.

Dr Jayne Foster

And how do you decide what to test?

Dr Lisa Kerr

So, essentially, we have four reasons for testing.  The different types of testing are called, responsive, programmed, external and maintenance testing. So, if we go to responsive testing, that usually follows when something has already happened in the market. So, for example, there's an adverse event, or somebody has reported a problem or complaint to the TGA, and that’s referred to the laboratories if our testing can assist in the investigation. We don’t usually decide whether we do the testing here. We just swing into action when we are needed.

The other type of testing that we do is programme testing. And that’s where we monitor the quality of products. So, that is, essentially, preventative testing, if you like. We,  we tend to,  use a lot of information from the rest of the, the TGA,  and we go and consult with TGA colleagues about what they think might need to be included on the,  testing programme based on what they're seeing in their work.

A good example is vaccines. So, we've been testing these products for many years. We're internationally recognised for our expertise in this area, such that the World Health Organization designated us as one of their collaborating centres for this particular type of expertise back in 1983.

We have a risk assessment process for this type of testing, which is based on ISO 31000 that helps us to determine what makes it on to our final testing plan.

The other two types of testing, the external and maintenance testing. So, external testing is where we receive samples from overseas governments the World Health Organization and other aid agencies. We test when we have the capability and capacity to do this type of work.

One of the major examples for this type of testing is the Pacific Medicines Testing Programme, which we run jointly with the Department of Foreign Affairs and Trade. In this programme, 12 of our Pacific Island neighbours can send samples to us without having to pay for the testing. And we also provide them with support and advice about the quality of medicines.

For maintenance testing, that’s the type of testing that, we do when we’re trying to develop methods to train our staff. We test internal samples, etc.

Dr Jayne Foster

So, what happens if a product actually fails testing?

Dr Lisa Kerr

We usually, well, we always issue a certificate to the sponsor.  And we also give the sponsor information on how to engage with us to, to talk about the failed test result.  we always listen to what that explanation might be. There might be a good explanation for that.  Generally, what we expect is that, the sponsor will have, their own testing results to come back to us with and we enter into a negotiation with that.

If it's determined that the fail is, a real result, then, we will start talking with other parts of the TGA, such as the recalls area. If it’s a minor issue, such as a label deficiency, we generally just liaise with the sponsor to try and resolve that, that issue, as soon as we can.

It’s important to note that the majority of the products that we test, overall are compliant.  And that in many, many cases, our testing actually exonerates the sponsor and the manufacturer in, in a problem or complaint case. So, for example, there might be a problem or a complaint about a product, and it turns out it’s because it hasn’t been used according to the label.

Dr Jayne Foster

Yeah, of course.

Dr Lisa Kerr

That, that sort of thing.

Dr Jayne Foster

And do we publish the results of the testing we do?

Dr Lisa Kerr

Well, it’s interesting that you say what you just said. So, we, we actually, publish statistics on our testing results. So, you can actually see the overall percentage fail rate in the statistic reports that the TGA publishes.

We also publish, line by line, the test results which go into a database, which are available on the TGA website. And about a year and a half ago, we started, publishing some more consolidated reports. So, instead of line by line, you can actually see a bit of a story behind why we decided to test those particular products, because we, we. It's unusual for us to actually test a single product at a time. It’s usually grouped for a particular reason.

So, our published test reports will tell you why we had to test in the first place. How we went about deciding which exact samples to test, what methods we used, what the results were, and what we did about them, if there was any failed results there.

So, for example, the types of reports that we have on the website at the moment include a large study on breast implants. We have facemask, results up there. We've published consolidated reports on vaccines.  And we’ve got one up there at the moment on medicines that contain green-lipped mussel extract.

Dr Jayne Foster

So, we're really interested to hear a bit more about this current facemask testing that’s under way. This is something that interests a lot of people. Could you tell us a bit more about that, Lucan?

Lucan Baillie

Sure, Jayne.  So, as you'd be aware, facemasks are an important tool for preventing the transmission of COVID-19. Since the pandemic started, there's been a huge increase in demand and supply of these types of medical devices, both, in Australia and, around the world.

To make sure that the products on the Australian Register of Therapeutic Goods, made at regulatory requirements, and perform as intended, the TGA started a review of facemasks and respirators in early 2020. As part of this review, we're undertaking laboratory testing.  And this is really important to ensure that our frontline healthcare workers who rely on these products every day are protected.

So, the TGA Laboratories developed capabilities to test surgical masks and respirators. The things we do when we test these products, include visual inspections. So, here, we’re checking for any, any obvious quality defects, and to make sure the products are correctly labelled.

We do fluid resistance testing to check that facemasks and surgical respirators are resistant to penetration by blood or any other bodily fluids. We do particulate filtration testing. So, this test, we check that respirators can filter out very small particles. And these particles can carry viruses like COVID-19. And we also conduct sterility testing to confirm that products that are marked as sterile are actually sterile.

So, so far, we've received over 1,000 products for testing. And we’re publishing the results of tests on our website.

Dr Jayne Foster

Wow, that’s a lot of facemasks, over 1,000. So, how are these generally received when they arrive at TGA, Lucan?

Lucan Baillie

So, Jayne, it’s really important that if you're requested to submit samples to the TGA, they're clearly identified, so, we know what actual product it is. So, sponsors should make sure they complete any of the forms that are requested to be filled in, and supply the products in the complete, finished packaging that will be supplied to the end user. This way we can properly assess all the labelling, as well as the quality of the product.

Dr Jayne Foster

Wow. What's the most interesting, kind of, packaging that facemasks have arrived in?

Lucan Baillie

Oh, unfortunately, sometimes we receive just packets of or blank envelopes with facemasks stuffed inside, and no identifying information. So, very tricky to try and work out what we’re testing and whether it complies with any labelling requirements.

Dr Jayne Foster

Yeah, I imagine that would make your job quite difficult.

Dr Lisa Kerr

So, Jayne, it’s often very useful for us to get samples with the ARTG numbers, particularly for medical devices. So, one of our previous projects that we ran on medical devices, we received samples that just came to us unpackaged. So, we didn’t really know which sponsor they belonged to. We could have a good guess at it, but it was sent to us just in a supermarket shopping bag, which is not appropriate.

Dr Jayne Foster

How can people find out more information about the TGA Laboratories?

Dr Lisa Kerr

Oh, Jayne, there's a lot of information on the TGA website about us. So, that includes details of our testing programme the international work that we do, and our involvement in the broader regulatory programme.

Dr Jayne Foster

Thanks very much, Lisa and Lucan. This has certainly clarified the role of the TGA's Labs and explained more about the extremely important work that you do in relation to ensuring the safety of products for the Australian public. Thank you for joining us today.

In our next episode, we’ll be discussing Australian manufacturing licenses and good manufacturing practice. So, please hit subscribe in the Podbean app or wherever you listen to podcasts, and be sure to check out our website at www.tga.gov.au for more information on the regulation of therapeutic goods in Australia.