Any site manufacturing a therapeutic good must be approved by the TGA as following Good Manufacturing Practice (GMP), before the therapeutic good manufactured at the site in question can be listed, registered, or sold in Australia.
Facilities manufacturing medical devices must hold a conformity assessment certificate from the TGA, and sites manufacturing listed or registered medicines must hold a License to Manufacture (Australia) or a GMP Clearance number (overseas sites). An overseas manufacturing site can be approved by the TGA via three methods.
- Mutual recognition agreement (MRA): The TGA accepts certification issued by the regulatory agencies of countries with which it has a MRA. The applicant must provide a certificate of GMP compliance. Assessment of the certificate is subject to a fee, and the process may be subject to additional charges depending on the level of involvement required by the TGA. A GMP Clearance number under a MRA should be issued within 15 working days. We can advise corrective actions to address any GMP deficiencies found by the regulatory agencies that may hinder the approval of the GMP certificate as well as assist with the TGA approval process.
- Compliance verification : If a country does not have an MRA with Australia, but they do have a memorandum of understanding or membership with the Pharmaceutical Inspection Co-operation Scheme (PIC/S), GMP clearance can be obtained via the compliance verification method. Applicants must submit an evidence package including a GMP inspection report and specific manufacturing documentation (a list of the regulatory inspections conducted within the past 3 years and a copy of the most recent inspection report; details of any regulatory actions in the past 3 years; site master file, quality manual or equivalent; GMP agreement between the sponsor and the manufacturer; list of products intended for supply in Australia; copy of the procedures for release for supply of products.) NHP Consulting has experts in GMP compliance and can help in each step along this process
- TGA on site audit If neither of the two options above are possible for the manufacturing site in question, the site may be accredited by an on-site inspection by the TGA. We can provide assistance by participating in the audit and providing formal response and corrective actions for any deficiency found by the TGA. NHP Consulting can perform a paper audit of your manufacturing facility to identify aspects of non-compliance with GMP, and assist with TGA registration for Canadian sites through the MRA. We can oversee the compilation of evidence packages for GMP-clearance applications for foreign sites not covered under an MRA via the compliance verification method outlined above.
NHP Consulting will provide all regulatory documentation to achieve market compliance for the Australian marketplace.