Obtaining a TGA Licence for a Sterile Compounding Facility
If you are a sterile compounding pharmacy seeking to obtain a regulatory approval e.g. a TGA manufacturing licence or comply with the GMP relating to the manufacture of sterile products, we can help.
In 2008, we helped Wesley Pharmacy become the first privately-owned cytotoxic compounding facility in Australia to achieve TGA manufacturing licencing. Our experience has steadily grown as we have repeated this many times within Australian and New Zealand, for other sterile compounding pharmacies who are targeting the oncology drug compounding market.
Services you may need include:
- Designing, building and validating clean rooms
- Implementing a Quality Management System
- Training staff in quality management and sterile product manufacture
- Risk assessment and management
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 – assessing what needs to be done to your current facility and processes to comply with the TGA’s requirements as well as other appropriate regulations such as Drugs & Poisons and Work Health and Safety.
- 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 sterile medicine, such as a chemotherapy drug, compounded in a TGA-licenced pharmacy. Our consultants trained in ‘Lean’ principles and can provide practical help in streamlining processes to reduce costs, using their pharmaceutical manufacturing experience. This includes managing the costs of running clean rooms, holding high value, low margin stock and reducing staff costs.
- Managing the recurrent costs and continual effort required to operate such a TGA-licenced facility – which 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
- Managing the risk associated with manufacturing and dispensing dosages of highly toxic drugs such as chemotherapy medication. For example, what would be the outcome of a label mix-up? What can be put in place to minimise this happening?
PharmOut’s engineers and architects can help design and implement the equipment, systems and processes you will need to produce high quality, sterile and safe compounded medicines and meet the TGA’s requirements.
Contact us if you would like to discuss your plans and what we can help you with.