95. How does the TGA audit manufacturing processes – did it fly to the US/Europe to inspect the manufacturing facilities of the Covid vaccines? 96. Does the TGA engage in spot audits of medical practices, pharmacists etc to ensure that the vaccines are being stored correctly at the appropriate very cold temperatures? 97. Could the TGA outline the KPI’s it uses to determine that Quality assurance processes around vaccine production and handling are of the highest quality?

Question Number: 111
PDR Number: SQ22-000143
Date Submitted: 24/02/2022
Department or Body: Department of Health

95. The Therapeutic Goods Administration (TGA) performs both desktop audits of submitted documentation and conducts onsite or remote inspections of manufacturers. The desktop assessments can include inspection evidence from comparable overseas regulators with whom Australia has Mutual Recognition Agreements. No onsite inspections by the TGA of overseas manufacturers making COVID-19 vaccines were necessary to date because the manufacturing facilities had been inspected by major global regulatory agencies from the US, UK and/or European countries.

96. The TGA does not have any legal role in auditing medical practitioners or pharmacists. The Australian distribution chain for COVID-19 vaccines is managed by the Vaccine Taskforce, under Operation COVID Shield.

Under the former government’s COVID-19 Vaccination Program, all primary care sites approved to participate in the program need to complete the Site Readiness Checklist and Declaration. They are required to complete components of the declaration based on the vaccine type(s) they have been approved to administer. In addition, all staff involved in handling and administering vaccines are required to undertake COVID-19 Vaccination Training.

As administrators of vaccines, all primary care sites are required to adhere to the National Vaccine Storage Guidelines ‘Strive for five’. These guidelines stipulate a self-audit tool, with audits to be conducted at minimum every 12 months or more frequently if required. In addition, a unit within the Vaccine Taskforce receives reports of any vaccines which have not been stored at approved temperatures, and requires their disposal if they are anticipated to have had a quality loss. The TGA provides technical advice to this unit as required.

97. In addition to confirming that manufacturing is performed at sites that meet Good Manufacturing Practice (GMP) standards, further documents and studies must be submitted to the TGA as part of the application to register the product in Australia. These include a description of the manufacturing process, as well as sterility, stability and batch analysis data. The data must be in accordance with Australian and international guidelines and standards. Additionally, the TGA laboratories carry out batch release processes for each vaccine batch prior to release and supply to the Australian market to ensure it is within the approved specifications.

For more information please visit the TGA website at: www.tga.gov.au/covid-19-vaccines, www.tga.gov.au/batch-release-assessment-covid-19-vaccines, and www.tga.gov.au/standards-guidelines-prescription-medicines.