If you are a compounding pharmacy, making non-sterile products, you can create a competitive edge by obtaining a TGA licence for your facility.
Obtaining a TGA Licence for a Compounding Facility
Based on our experience, compounding pharmacies aiming for TGA licencing seem to have the most difficulties with the following areas:
- Navigating through the overlap between a pharmacy licence and a TGA licence – it’s often not easy to work out where one stops and the other starts.
- Gap analysis –what needs to be done to your current facility and processes to comply with the TGA’s requirements as well as any other regulations you must comply with.
- Managing the increased costs associated with a dispensing episode. There is a significant difference between dispensing a packaged prescription medicine compared to preparing and dispensing a compounded medicine from a TGA-licenced pharmacy. We can help streamline processes to reduce these costs, using our pharmaceutical manufacturing experience.
- Managing the recurrent costs and continual effort required to operate such a TGA-licenced facility can be onerous and expensive.
- Justifying stated shelf life for a product to the TGA
- Preparing for a multi-day TGA audit and responding to any findings
PharmOut can help design and implement the equipment, systems and processes you will need to produce high quality and safe compounded medicines and meet the TGA’s requirements.
Services you may need include:
- Designing, building and validating a building for compounding operations
- Implementing a Quality Management System
- Training staff in quality management and product manufacture
- Risk assessment and management
The Green Dispensary, based in South Australia, is a great example of a pharmacy that has obtained a TGA licence for their purpose-built facility, in which they compound a range of custom medications for patients. The rigour that the TGA-licence introduces means patients can have a high level of confidence in the safety and effectiveness of the medications made specifically for them.
Contact us if you would like to discuss your plans and our architects, engineers and Quality experts can help you.