Manufacturer compliance history

29 April 2013

A manufacturer's compliance history is used as part of the TGA inspection frequency matrices to help determine the frequency of manufacturer site inspections.

The manufacturer's compliance level is determined by the number and nature of deficiencies (medicines and biologicals) or non-conformities (medical devices) 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.

Compliance levels

The TGA uses a system of classification which rates each deficiency or non-conformity 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 or non-conformities were found, which are of a relatively minor nature.

Compliance level A2 = Satisfactory

A2: Few major deficiencies (not more than five) and/or a larger number of minor deficiencies or non-conformities were found. No critical deficiencies were found.

Compliance level A3 = Basic

A3: A large number of major (more than five, not more than 10) and/or a large number of minor deficiencies/non-conformities 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.