As a TGA GMP consultant, I’m often asked: “How frequently will I be inspected?”

As a TGA GMP consultant, I’m often asked: “How frequently will I be inspected?”

Many manufacturers want to know how often they will be inspected – which can be a complex question to answer. The TGA employs a risk-based approach to the frequency of manufacturer inspections, in addition to numerous other factors.

How does the TGA determine inspection frequency?

The TGA uses inspection frequency matrices to guide the frequency of inspections. These matrices take into account:

  • The product and process risks
  • The manufacturer compliance history


These are then used to define the probable re-inspection timeframe.

Re-inspection frequency matrix for medicines and blood, tissue and cellular therapies

Risk CategoryA1 Compliance RatingA2 Compliance RatingA3 Compliance RatingUnacceptable Compliance Rating
High24 months18 months12 monthsDetermined by Review Panel
Medium30 months20 months12 monthsDetermined by Review Panel
Low36 months24 months12 monthsDetermined by Review Panel


Re-inspection frequency matrix for medical devices

Risk CategoryA1 Compliance RatingA2 Compliance RatingA3 Compliance RatingUnacceptable Compliance Rating
High16 months14 months12 monthsDetermined by Review Panel
Medium High18 months16 months12 monthsDetermined by Review Panel
Medium Low20 months16 months12 monthsDetermined by Review Panel
LowN/AN/AN/ADetermined by Review Panel


Does the TGA take any other factors into account?

In addition to the inspection frequency matrices, the TGA will collect information to create a Manufacturing Profile. This is information that may be updated at any time to reflect recent events or changes to risk factors. Some of these include:

  • Emerging trends
  • Recalls
  • Adverse events
  • Results of laboratory testing
  • Feedback and inspections undertaken by other regulators
  • Significant changes within the company, including:
    • Key personnel appointments or resignations
    • Building
    • Key equipment
    • Product lines
    • Intention to cease business


Where necessary, a special inspection may be undertaken ahead of the next planned inspection as a result of one of these factors.

The TGA will also consider previous inspections and manufacturers who have been found to have minimal compliance ratings will take priority over new manufacturers when inspections are scheduled.

Note for Medical Devices

Under the regulatory framework for medical devices, sites are required to have their quality systems re-certified at five year intervals. At least two surveillance inspections will be conducted between these intervals, meaning that the entire quality system will be reviewed in this period.

You might also be interested in these other blogs:
As a TGA GMP consultant, I’m often asked: “How long does it take to get a TGA manufacturing licence?”
As a TGA GMP consultant, I’m often asked… “Do you have any examples of Critical and Major deficiencies?”

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