The manufacturer's compliance level is determined by the number and nature of deficiencies (medicines and biologicals) found during inspections, and the manufacturer's response to the inspection report.
After the TGA receives the manufacturer's responses to an inspection report, the TGA reviews the manufacturer's compliance level. The results of this review are then communicated to the manufacturer.
The TGA uses a system of classification which rates each deficiency according to its potential for serious product failure and subsequent patient harm.
Manufacturer compliance can range from good to unacceptable.
Compliance level A1 = Good
A1: Few deficiencies were found, which are of a relatively minor nature.
Compliance level A2 = Satisfactory
A2: Few major deficiencies (typically not more than five) and/or a larger number of minor deficiencies were found. No critical deficiencies were found.
Compliance level A3 = Basic
A3: A large number of major (typically more than five, not more than 10) and/or a large number of minor deficiencies were found. No critical deficiencies were found.
Not rated = Unacceptable
One or more critical deficiencies and/or a large number of major deficiencies were found.
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.