A practical guide to optimising GMP straight from Australia’s regulator.

Our Head of Listed Medicines, Tatiana Jones, attended the TGA GMP Forum 2024 in Melbourne. Here are her key takeaways.

Across two days, I gained invaluable insights, participated in discussions and left with practical takeaways directly from the TGA at the recent TGA GMP Forum. For anyone in the complementary medicine space this reinforced the importance of quality and compliance in our industry.

We covered a lot, but I’ve boiled it down into some key takeaways for startups, raw material suppliers and contract manufacturers.

Start-ups

For many brands staring out with a complementary medicine supplement business, the process can go a little bit like this: 💡➡️ product ➡️ marketing – or so they hope. Sometimes in the mix there’s a document discussed called a GMP Agreement, and reading it can seem a little bit like double-Dutch. Who does what, when, why and how – and in all honesty, whilst it’s a vital piece of documentation to have, it’s not the only thing you need to know about and the reality is it’s only ever dusted off from the drawer when something goes wrong. This means, for many startups, understanding the complexities of Good Manufacturing Practice (GMP) compliance can be frightening – but I’m here to tell you it is paramount to your success and it’s actually not that complex. Understanding and embedding GMP principles from the get-go can protect your business from recalls, regulatory action and loss of consumer trust.

Here’s a quick checklist of what you need so you can start with the end in mind and grow with strong processes:

• Training – get to know what you don’t know – if reading the PIC/s guide to GMP doesn’t take your fancy, we can boil it down into manageable bite sized pieces for you to digest – ask us for a training.
• Quality manuals – make sure you have them – and use them – but do you know what should go in them?
• Standard Operating Procedures (SOPs) – what happens if the ‘proverbial’ hits the fan and you need to deal with a serious complaint? Do you have a process in place? How will you capture customer feedback and track trends?
• Batch records which meet regulatory requirements – can you trace your batch of product from start to end?
• Supplier Qualification – validate your suppliers, audit them and approve them – did you know you can ask to go and visit your manufacturer? Going on a tour of their facilities will help you understand how they work and how your product is made.
• Lastly, maintain clear and detailed documentation at every step it reduces the risk of non-compliance.

By implementing these basic GMP principles from Day 1, startups can build a strong foundation for growth and avoid the pitfalls of non-compliance.

Raw material suppliers

Considering the TGA GMP Forum from a raw material supplier’s point of view brought back memories of my old roles. Coming out of roles in raw material supply, means I know what’s important from both a raw material manufacturing perspective but also for brand marketers as well.  Positioning yourself as a trusted partner is key. When you’re in the raw material supply business, ensuring your processes align with TGA requirements will not only build client trust, it will also reduce the risk of deficiencies during audits, but most importantly position you as a preferred supplier. Brands and contract manufacturers alike know how difficult it can be to deal with raw material suppliers who send documentation in dribs and drabs, or it’s inaccurate or incomplete, or just plain terrible.

From a TGA perspective, suppliers must demonstrate sufficient processes relating to testing protocols and traceability. Control of ingredients is essential and you can do this by ensuring specifications, approvals and testing is up to standard. Standard? What standard? Ingredients for use in Listed medicines must comply with default standards or demonstrate compliance through identification and assays if no standard exists. For raw material suppliers how are  sourcing ingredients overseas, I recommend you find manufacturing sites with independent certifications, such as US FDA, Chinese SFDA or EU GMP certification because this adds an extra layer of quality assurance – and let’s face it gives you something more to talk about on your sell sheets if you can demonstrate multiple different quality accreditations.

Contract manufacturers

Without you, our industry wouldn’t survive. There’s very few brands who can afford to make their own products at their own site, which means contract manufacturers play a critical role keeping our industry afloat. They are also the one’s tasked with ensuring finished products meet GMP standards.

The team at the TGA GMP forum emphasised the importance of rigorous cleaning validation, ingredient control and process validation. I’ve summed up the key points as follows:

• Cleaning validation should go beyond the ‘visually clean’ acceptance criteria and consideration given to addressing any additional concerns such as microbiological burden, residual chemicals and any potential allergens which are used on equipment. This is especially important if you’re considering probiotic manufacturing.
• Control of single component ingredients by identification (ID) must be completed on each lot and/or each delivery received along with verification that starting materials meet their specification through testing and review of supplied CoAs. As contract manufacturers you need to be seeing that there’s evidence that the materials are manufactured under acceptable controls do this supplier approval by either questionnaire or audits of the manufacturer of the starting material.
• Control of API premixes is equally important. Did you know you can source API premixes from overseas provided the material is manufactured under acceptable GMP and quality?
• When it comes to root cause analysis within corrective and preventive actions (CAPA) the TGA want you to focus on correcting the root cause, not just the symptoms. Focus on how and why rather than the who and consider how root cause can be prevented in the future.

Keeping all of the above in mind means as contract manufacturers you can continue to uphold high quality standards and maintain compliance.

The above is just a short snippet of what I learnt over the two days. If I could have you take away only one thing from reading this blog, know this

Getting the basics right is essential for delivering quality products.

Whether you’re a startup, supplier or contract manufacturer adhering to GMP principles ensures long term success and are the backbone for sustainable growth in the complementary medicine industry.

We’ve been in business for 10 years, our team has 100 years of cumulative experience in this industry, and they’ve worked in regulatory affairs, quality assurance and raw material supply. There’s not much we haven’t seen!