Audit response

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

Re-inspection frequency matrix for medical devices

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.

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