Quality Assurance (QA): Is There Any Substance to the Quality Assurance
Join host Brett Davidson interviews Nick Bova, Managing Director of Bova, to explore the reality behind Quality Assurance in veterinary compounding.
With some compounding pharmacies claiming Quality Assured products/facilities, Brett and Nick dive into what “Quality” truly means, how it’s regulated, and why the standards are often misunderstood. Drawing on Nick’s experience from establishing Bova UK under strict GMP regulations—standards that Australian pharmacies are not required to follow—they discuss the lack of oversight in the Australian veterinary compounding industry.
The QA program Bova has implemented is a unique approach developed in consultation with regulatory bodies. This insightful conversation sheds light on the critical differences in global veterinary compounding practices and the real meaning of quality assurance.
Transcript
Quality Assurance (QA): Is There Any Substance to the Quality Assurance
Introduction
Welcome to the Bova Aus podcast, where we explore veterinary medicine from development through to delivery. This episode is intended for veterinary professionals. If you’re a pet owner, please consult your veterinary surgeon with any concerns regarding treatment.
Welcome Back
Brett:
Hey everyone, welcome back to the Bova Aus podcast. It’s been a while! I’m joined today by Nick Bova—welcome, Nick.
Nick:
Hey Brett, good to be here. It’s definitely been a while. Hopefully we’ve still got a couple of listeners left!
Brett:
I’ve texted my mum, so that’s one. You text yours and we’re good to go.
Nick:
Exactly!
What Do We Mean by “Quality Assurance”?
Brett:
There’s been a lot of change at Bova Aus recently—new facilities, new products, and collaboration with Nextmune and Bova UK. But today, we’re addressing one of the most common questions we hear: what does “quality assurance” really mean?
Nick:
It’s a great question. “Quality assured” is used everywhere in the industry, but unless it’s clearly defined and backed by process, it’s just a label. Let’s unpack what sits behind that term.
Building a Quality Framework – Lessons from Bova UK
Brett:
Setting up Bova UK under Good Manufacturing Practice (GMP) was a turning point for you. What did that involve?
Nick:
It was a game-changer. We worked to MHRA standards, which meant validating equipment, sourcing from GMP suppliers, training staff rigorously, installing pressure-controlled rooms, managing cold chain logistics—every element was tracked and documented. It gave me a new respect for what “quality” truly requires.
Adapting UK Standards for Australia
Brett:
When you brought that experience back to Australia, what had to change?
Nick:
A lot. At the time, Australian compounding regulations didn’t support batch production or pre-preparation, both of which are vital for proper testing and validation. So we worked with APVMA to create a regulatory pathway that allowed us to assure product quality before it’s prescribed.
The Limitations of Traditional Compounding
Brett:
That’s quite different from traditional compounding here, right?
Nick:
Exactly. In traditional settings, a product is only made after the script is written. You can’t destructively test a 100 mL batch if that’s all you’ve got—so no real quality testing occurs.
No Standardisation = No Consistency
Brett:
And there’s no consistency between pharmacies?
Nick:
Correct. You could get wildly different results for the same compound from two pharmacies—different actives, excipients, methods, or equipment. There’s no requirement to prove capability, especially for sterile injectables.
What Bova Means by “Quality Assured”
Brett:
So what does “quality assured” mean at Bova?
Nick:
It means:
- The batch was prepared in advance under GMP-like conditions
- The final product was tested and confirmed to meet potency, uniformity, and stability standards
- If it fails, we reject it—simple as that
Quality of Raw Materials
Brett:
Where do your ingredients come from?
Nick:
Wherever possible, we source actives from GMP-certified manufacturers. Unfortunately, not all compounders do. In some cases, ingredients come from unverified suppliers—and vets never know.
What Vets Should Ask
Brett:
So how can vets ensure what they prescribe is quality assured?
Nick:
Ask to see the Certificate of Analysis (CoA) for the final product—not just for the active. If they can’t provide that, there’s no quality assurance.
The Problem with “QA” as a Buzzword
Brett:
There’s no formal regulation of the “quality assured” label in Australia, is there?
Nick:
That’s right. Anyone can say it. That’s why we’ve been pushing for external auditing—we want vets to know that an independent authority has validated our processes.
Signs of Industry Movement
Brett:
Are regulators taking action?
Nick:
Yes. The AVA and other industry bodies are beginning to understand that without enforceable standards, there’s too much variability and too much risk.
Final Thoughts – What Vets Need to Know
Brett:
So what’s your take-home message?
Nick:
If you’re prescribing compounded medications:
- Ask about the manufacturing process
- Ask where the raw materials come from
- Ask whether the final product has been tested
Don’t assume “compounded” means “standardised.” It doesn’t—unless the pharmacy goes the extra mile.
Outro
Thanks to Nick Bova for joining us.
For more info, visit the Bova Aus website or contact your territory manager.
This podcast is intended for veterinary professionals. Pet owners should consult their own vets for medical advice.
