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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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16: Issuing the inspection report

Once we have reviewed and accepted your responses, we will close out the inspection and issue an inspection report to the manufacturer. The inspection report is a comprehensive account of the inspection, including:

  • the scope of the inspection
  • the manufacturing, quality control and quality assurance processes and systems inspected
  • the list of observed deficiencies
  • an assessment of the manufacturer's response to any deficiencies
  • the manufacturer compliance rating
  • any proposed conditions on the site licence or certification
  • proposed reinspection dates
  • confirmation of the final outcome and inspection closeout
  • any proposed amendments to site authorisations or certifications (only applicable to licences or certifications that are in force)

Compliance rating

You will receive a compliance rating of either:

  • A1 (good)
  • A2 (satisfactory)
  • A3 (basic)
  • unacceptable

We consider your compliance rating and the complexity of your operation when we determine the frequency of follow-up inspections.

Overview of the inspection closeout process

Flow diagram: Overview of the inspection closeout process (pdf,101kb)

This text representation of this flow chart is provided as a list with numbered steps.

Inspection Close-Out Process:

If a potential safety issue (which presents a risk of harm to consumers) is identified, including during inspection, this is referred to the Director, Inspection Section within 24 hours, for escalation within TGA.

Conduct inspection and no deficiencies are found
  1. If zero deficiencies are found during the inspection
    • Four weeks after inspection, TGA provides the inspection report, which includes the date of the next inspection and inspection duration (taking into account inspection of actions)
    • Compliance rating: A1 manufacturer (fast track close out), Inspection closed out 4 weeks after end of inspection
    • End Flow Chart
Conduct inspection and leave list of deficiencies
  1. If zero major deficiencies are found during the inspection
    • Step 1: two weeks after inspection, TGA issues a final list of deficiencies and request a list of actions to be provided within 4 weeks
    • Step 2: four weeks after receipt of list of actions, TGA provides the inspection report, which includes the date of the next inspection and inspection duration (taking into account inspection of actions)
    • Compliance rating: A1 manufacturer (fast track close out), Inspection closed out 10 weeks after end of inspection
    • End Flow Chart
  2. If 1-5 major deficiencies are found during the inspection
    • Step 1: four weeks after inspection, TGA issues a final list of deficiencies and request CAPA plan to be provided within 4 weeks (first response)
    • Step 2: Is CAPA plan acceptable?
      1. Yes - four weeks after receipt of CAPA plan or additional information, TGA provides inspection report, which includes the date of the next inspection and inspection duration (taking into account inspection of CAPAs)
      2. No - up to a maximum of 2 additional requests for information. Requests are sent four weeks after receipt of response
        1. If CAPA plan is not acceptable after 3 responses, referred to review panel
    • Compliance rating A2 manufacturer (Acceptable), Inspection closed out:
      • One response, 12 weeks after end of inspection
      • Two responses, 20 weeks after end of inspection
      • Three responses, 28 weeks after end of inspection
    • End Flow Chart
  3. If 6-10 major deficiencies are found during the inspection
    • Step 1: four weeks after inspection, TGA issues a final list of deficiencies and request CAPA plan to be provided within 4 weeks (first response)
    • Step 2: Is CAPA plan acceptable?
      1. Yes - six weeks after receipt of CAPA plan or additional information, TGA provide inspection report which includes, the next inspection and inspection duration (taking into account inspection of CAPAs)
      2. No - up to a maximum of 2 additional requests for information. Requests are sent four weeks after receipt of response
        1. If CAPA plan is not acceptable after 3 responses, referred to review panel
    • Compliance rating A3 manufacturer (Acceptable subject to acceptable CAPA plan) Inspection closed out:
      • One response, 14 weeks after end of inspection
      • Two responses, 22 weeks after end of inspection
      • Three responses, 30 weeks after end of inspection
    • End Flow Chart
  4. If ≥10 major deficiencies and/or ≥1 critical deficiency (Unacceptable) found during the inspection
    • Step 1: Review Panel assessment
      1. If unacceptable TGA determine appropriate regulatory action(s) - End Flow Chart

        OR

      2. Conduct close out inspection: is there sufficient evidence of effective CAPAs?
        1. No - If unacceptable TGA determines appropriate regulatory action(s) - End Flow Chart
        2. ii. Yes - six weeks after receipt of CAPA plan or additional information, TGA provides inspection report, which includes the date of the next inspection and inspection duration (taking into account inspection of CAPAs)
      • Compliance rating A3 manufacturer - acceptable subject to acceptable CAPAs. Inspection closed out:
        • One response, 14 weeks after end of inspection
        • Two responses, 22 weeks after end of inspection
        • Three responses, 30 weeks after end of inspection
    • End Flow Chart

Reinspection duration

If necessary, we may extend the next onsite inspection to allow us to assess the corrective actions taken by the manufacturer. This is more effective than requesting objective evidence for assessment offsite. This approach aligns with those taken by our international regulatory partner agencies.

The amount of extra time required for the next inspection will depend on the level of compliance. Where no major deficiencies were identified at the last inspection, an extension will not usually be necessary. However, depending on the number of deficiencies identified and compliance rating, the next inspection could be extended by ½ day for A2 and a full day for A3.

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