Australia – TGA begins virtual GMP inspections of domestic manufacturers

Australia’s Therapeutic Goods Administration (TGA) has begun conducting virtual inspections as part of a new approach to oversight of domestic manufacturers during the COVID-19 pandemic.

The coronavirus continues to shape TGA operations even as Australia is starts to relax its lockdown. The plan for handling domestic good manufacturing practices (GMPs) inspections shared this week reflects an assumption that in-person assessments of drug production facilities are likely to be a challenge for some time.

With routine onsite inspections on hold, TGA is assessing both the need for inspection and the risk associated with not doing so in-person. Based on the assessment, TGA will take one of four options…