Source: Australian Department of Health – Therapeutic Goods Administration
As part of its Pharmacovigilance Inspection Program (PVIP), the Therapeutic Goods Administration (TGA) conducted a total of ten inspections of Australian sponsors from 1 September 2017 to 31 December 2018.
A total of ten routine pharmacovigilance inspections were completed. There were no ‘for-cause’ inspections or re-inspections.
- no critical deficiencies
- 50 major deficiencies
- 29 minor deficiencies.
Pharmacovigilance Inspection Program metrics report: September 2017 – December 2018
- Inspections conducted
- Inspection findings
- Common areas of findings
- Comparisons of inspection findings over time
- Appendix I: Inspection type definitions
- Appendix II: Inspection finding definitions
- Appendix III: Categorisation of findings