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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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21: Conducting follow-up inspections

Follow-up inspections can be routine or special.

Routine inspections

We schedule routine follow-up inspections and advise the Australian manufacturer or Australian sponsor shortly before the inspection date. The frequency of routine follow-up inspections depends on the level of compliance at previous inspections and level of risk of products being manufactured. Generally you do not need to submit applications for routine reinspections or to request recertification; the TGA Business Services will automatically generate an application for re-inspection based on the frequency recommended following the inspection.

Routine follow-up inspections cover the full scope of manufacture. We need to be satisfied that you:

  • continue to comply with the relevant codes and standards
  • continue to comply with the conditions of the licence or certification
  • have paid all fees related to licence or certification

We have target timeframes for issuing inspection reports following re-inspections.

Special inspections

We may conduct special inspections:

  • to complete the closeout of a routine inspection where we need to follow up identified deficiencies on-site.
  • as a result of GMP compliance concerns
  • for variation applications.

These inspections may focus on specific areas.

We may conduct unannounced inspections when necessary, particularly if we have concerns about GMP compliance.

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