TGA inspectors assess and verify RFS arrangements.
During inspections, we require access to certain information to help determine compliance with the PIC/S guide to GMP. This information below is:
not an exhaustive list of what we will assess
outlines some of the information you will be required to make available to us.
During an inspection we will verify that the manufacturer has ensured the authorised person’s level of education and expertise is appropriate using the training arrangements in the manufacturer’s pharmaceutical quality system.
Product quality reviews
PQRs are expected to be available for review during TGA on-site GMP inspections of manufacturers responsible for performing release for supply.
Release for further processing
During GMP inspections of (contract) manufacturers performing manufacturing steps prior to release for supply, but not the actual release for supply itself, the PQR data relevant to that manufacturing step submitted to the manufacturer performing release for supply are expected to be available for review.
Ongoing stability program
During an inspection of the RFS manufacturer, ongoing stability data are expected to be available for review. This could be by:
staff at the RFS site requesting the data
direct transfer of the data to the TGA inspector, if there are confidentiality issues.
Where manufacturing occurs across multiple sites, a clear mechanism to make the requested data available to inspectors needs to be detailed in your GMP agreement.
Overseas manufacturers are assessed and verified through on-site GMP inspection and/or the Compliance Verification (CV) process, except for CVs based on evidence from MRA regulators in their own country. These assessments are done via the GMP agreement(s) with the contract givers and involve the assessment of the release for supply procedures, including marketing authorisation requirements.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.