OOS For Finished Products
OOS For Finished Products
OOS For Finished Products
115
% Assay
100
limit, but appears “irregular’ or outside 95
the trend of previous results. 90
• Or routine trending shows that it will not 85
Note: Changes listed above may require TGA approval in order to implement.
Health Hazard Assessment
Responsibilities of sponsors
• All sponsors of products must ensure that it has an appropriate system
of pharmacovigilance (PV) in place in order to assure responsibility and
liability for its products on the market and to ensure that appropriate
action can be taken when necessary.
• A sponsor should have a permanent and qualified person for PV who
has experience in all aspects of PV and if not medically qualified should
report or have access to a medically qualified person.
QUESTIONS?