I work in a practice associated with a TGA licensed dispensary service. The compounding dispensary bases its operation on a quality management system called Good Manufacturing Practice (GMP). It’s a complex and involved system of standard operating procedures, logbooks, forms, training manuals and supplier profiling.
The TGA inspectors recently visited the premises, spending two days forensically looking over documents, questioning work flow processes, and checking logbooks and forms to make sure the dispensary operates in line with the international, pharmaceutical standard. As a sole operator and dispenser, you might say: “This is not relevant to me, because I don’t have to comply with those standards”. While that may be true, many aspects of the standard readily apply for non-GMP dispensaries and are still important to ensure quality products are provided to patients.
Admittedly, when first embracing the GMP practice, our team was overwhelmed by the requirements of such a standard but with the recent TGA inspection, we became acutely aware that the aim of a license is not just quality, but also to enhance safety and consistency.
It’s not just raw materials (liquid extract, granules and cream base), it’s also primary packaging materials (the one that touches the finished product, for example the bottles for liquid extracts or the pouches for the granules), labels, ink, dispensing utensils and much more.
So, how do you find the right suppliers for you? Well, we visit each one and assess fundamental criteria. For instance to reduce impact on the environment, we source local or State suppliers to Australia wide or international providers. We also actively discuss all of the criteria mentioned below to ensure they meet our standards and expectations.
• Relevant details on supply chain
• Manufacturer location (if they are a distributor or agent)
• Type of supplier (what type of material/product do they provide)
• What are their storage conditions
• Are they packaging / repackaging materials
• Information on the manufacturer’s site(s) and other relevant information
• GMP status and relevant details
• History of cooperation with our operation
• Quality system employed by manufacturer
• Testing methods if applicable
• Status of Certificates of Analysis (CoA), providers of Certificates and other relevant information
• Stability attributes and transportation requirements
• Ethical practice
The point that I am making is that we choose suppliers that best meet our standards, have similar values and a mission that best aligns with what we do. I feel this point is important. Working for the same cause opens space for collaboration and partnership and that’s the best outcome for everyone. Better products for us and our patients, greater impact as a whole on our industry. I feel that our profession can disqualify quality and choose a lower priced product. Personally, I want a product for my patient that comes from a source I am proud to be associated with, not that I feel I have to hide.
As this edition comes out in spring, perhaps it will provide you with the energy to review, revive and restructure your business to success! I would like to encourage you to look critically at your current suppliers. Make them business partners if you find their priorities and values align with yours, or consider finding new suppliers if they don’t. This will ultimately lead to a happier business, a prosperous partnership and a better outcome for your patients which affects our profession in the long-term.