Prior to the inspection, please ensure you confirm your readiness for inspection. An inspector will contact the manufacturing site(s) to discuss:
the members of the inspection team
any requests for additional information to support the application, such as:
the current Site Master File or Quality Manual
details of products manufactured since the last inspection (if relevant, for example for reinspection)
details of any significant changes made since the last inspection (if relevant, for example for reinspection)
communication and IT platform, where applicable
any other information the inspector deems relevant
We may request electronic copies of records or other documents, such as Standard Operating Procedures (SOPs), validation plans, lists of products manufactured, any regulatory actions taken (recalls or product alerts) et cetera.
In most cases, we will contact the manufacturing site to arrange the inspection; however, we may also need to contact the sponsor for information relating to the inspection.
All documents supplied to the TGA must be in English or accompanied by an English translation.
Documents should be provided in an electronic format.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.