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Pharmacovigilance inspection program: Guidance for medicine sponsors

Version 1.0, September 2017

1 September 2017

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Inspection reporting

Preparing inspection reports

Our inspection team will prepare an inspection report and associated close-out record for each pharmacovigilance system inspected.

Reporting an inspection

  1. Our inspectors will issue you the pharmacovigilance inspection report and cover letter in a timely manner - normally within 30 days of completing the inspection.
  2. If required, you will then be requested to prepare a corrective and preventative actions (CAPA) plan in the form of a close-out record on the template provided with the inspection report. You should provide the inspectors with the close-out record within 30 days of receiving the inspection report. On submission of the close-out record, you should also provide the inspector with comments on any major factual errors in the inspection report, as necessary. If we do not receive a response within the agreed time frame, this will be recorded in the inspection report.
  3. Our inspectors will assess the close-out record and any major factual errors identified in the inspection report will be noted and corrected in the final inspection report. An assessment will be made on the impact of any comments on the inspection findings and the adequacy of the proposed CAPA and proposed time frames.
  4. The assessment of the CAPA will be documented in the close-out record. If we do not accept the proposed CAPA or the proposed time frames of actions, additional follow-up and negotiation procedures will occur, until an agreement is reached.
  5. We will close the inspection when we have agreed on an acceptable CAPA plan. At this point, the lead inspector will sign the final inspection report and associated close-out record and issue these to you.
  6. Our inspectors may ask you for ongoing evidence of completion or updates on your CAPA activities.

Inspection report contents

The inspection report consists of five sections:

  1. Inspection-related data, including
    • details of the inspected site(s) and the main site contact(s)
    • inspection details including inspection type, scope, date and the names and roles of the inspectors
  2. Introduction to and summary of the inspection activities including the inspection's purpose, and background information on the sponsor and product range
  3. Inspection observations and findings
  4. List of any deficiencies observed during the inspection
  5. Name and signature of the person authorising the report on behalf of the TGA.

Content of the close-out record

We issue a close-out record with the inspection report to incorporate your CAPA commitments and our assessment of your CAPA.

The close-out record documents:

  • any deficiencies identified
  • the root cause of the deficiencies
  • the proposed corrective and preventative actions to the root cause
  • corrections to observed examples (if relevant)
  • objective evidence provided (if relevant)
  • proposed completion dates of CAPAs
  • any comments by the inspector
  • the final response acceptance.

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