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Pharmacovigilance Inspection Program metrics report: Sep 2017 - Dec 2018

20 March 2019

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.

Inspections identified:

  • no critical deficiencies
  • 50 major deficiencies
  • 29 minor deficiencies.

Pharmacovigilance Inspection Program metrics report: September 2017 - December 2018

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Contents

  • Summary
  • Background
  • 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