9: Determining the inspection type and scheduling the inspection
Determining the inspection type
We have developed a process to enable inspectors to undertake remote and/or hybrid GMP inspections where appropriate.
This process is a risk-based model where we evaluate various options available for inspections on a case-by-case basis, in consultation with relevant staff at each specific manufacturing site.
The inspection options include:
- a remote, virtual inspection with agreed communication tools and desktop review of information
- a hybrid approach including a desktop review and an on-site inspection
- an on-site inspection
When scheduling inspections, we take into account the type of product manufactured, the complexity of the manufacturing process, the size of the manufacturing facility et cetera. Based on your application, we will:
- determine the type of inspection
- determine the inspection team size
- determine the inspection duration
- select the inspectors and specialists who will conduct the inspection
Choosing the inspection team
The TGA will choose an inspection team. The team has delegated authority under the Therapeutic Goods Act 1989.
You may not request or refuse particular inspectors
The inspection team
Inspection teams are led by a Lead Inspector and supported by appropriately qualified and experienced inspectors and, where required, technical specialists. Technical specialists with current, specialised knowledge of the activities inspected can provide a relevant and practical review of critical aspects of the manufacturing process.
Some inspections may be carried out by an individual inspector.
Avoiding conflict of interest
We will not select inspectors or specialists to inspect manufacturers where there may be a real or perceived conflict of interest. An inspector cannot:
- have been employed by the manufacturer within the three years prior to the date of the inspection
- have a commercial or financial interest in the manufacturer
- be a significant shareholder in the manufacturer or the manufacturer's industry
- have been engaged by the manufacturer as a consultant within the last three years
Generally, no Lead Inspector will lead an inspection of a particular manufacturer on more than two consecutive occasions.
Arranging the inspection
- liaise with the manufacturer to determine the inspection dates
- schedule the dates for the inspection, although these may sometimes need to be changed
- undertake inspection related administrative arrangements, where applicable, including inspection costs, flights and travel allowance, in accordance with Department of Health travel policy
If we need to inspect more than one site overseas and are planning to travel to the sites, we will attempt to arrange multiple inspections for that trip. This usually results in some travel costs being shared among sponsors.
You cannot cancel a TGA inspection by submitting a desktop assessment via the MRA or CV pathways if we have confirmed the inspection dates with the manufacturer and begun arranging the inspection.