The TGA’s pharmacovigilance inspection program means that medicine sponsors can expect to be periodically inspected by the TGA. If TGA inspectors were coming to inspect your organisation in six weeks, would your pharmacovigilance system be inspection ready?
The data suggests probably not! According to the latest pharmacovigilance inspection program report, every single sponsor inspected in 2020 had at least 4 major deficiencies. Cumulatively, there were 2 critical deficiencies, 27 major deficiencies, and 16 minor deficiencies across 6 inspections.
Where do sponsors typically go wrong? Most deficiencies fell into these categories:
- Management of Reference Safety Information
- Collection, Collation, Management, and Reporting of Adverse Drug Reactions
- Management of Significant Safety Issues
- Quality Management Systems
- Pharmacovigilance Contact Person and QPPVA
- Post-Approval Commitments
Knowing where sponsors typically go wrong with meeting their pharmacovigilance obligations, is your organisation inspection ready?
Cpharm stands ready to help sponsors with meeting their pharmacovigilance obligations, including all the above categories. Whether you want to outsource elements of your pharmacovigilance system to an experienced service provider, need help implementing corrective and preventative actions to address an inspection report, or want to engage a pre-inspection audit of your pharmacovigilance system to assess your inspection readiness, get in touch with Cpharm!