Good Manufacturing Practice (GMP) clearances are required for overseas manufacturers when you are seeking to register or list your product on the Australian Register of Therapeutic Goods (ARTG). It involves the desk-top evaluation of these manufacturers using a combination of inspection reliance and desk-top audit.
The COVID-19 pandemic and several other contributing factors resulted in a backlog in GMP Clearance CV applications. Whilst the backlog is steadily reducing, we are implementing temporary risk-based measures to further expedite this reduction and improve processing times.
This webinar will provide an overview of the backlog reduction strategies, best practice approaches for industry and a Q&A session.
Speaker
Stephen Farrell, Director, GMP Clearance, Manufacturing Quality Branch, TGA
