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Guidance on the management of GMP compliance signals

for domestic and overseas manufacturers of medicines and biologicals
18 May 2021
Download Guidance on the management of GMP compliance signals


The guidance outlines the Good Manufacturing Practice (GMP) compliance requirements (according to the Manufacturing Principles) for manufacturing biologicals and medicines intended for supply in Australia and our framework for managing GMP compliance signals.

GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that each batch of a therapeutic good is safe, reliable and of consistent high quality.

This guidance applies to:

This guidance is not intended for manufacturers and sponsors of medical devices.

  • About this guidance
  • GMP for medicines and biologicals
  • Licensing, GMP certification and clearance requirements
  • GMP compliance signals
  • GMP compliance signals and sponsor / manufacturer responsibilities
  • Management of GMP compliance signal
    • Review and investigation of GMP Compliance signals
      • Risk assessments
      • Request for additional information
  • Compliance and risk framework for licensed manufacturers
  • Regulatory actions for domestic licensed manufacturers
  • Regulatory actions for overseas manufacturers
    • GMP Compliance signal review and investigation
  • Compliance and enforcement tools available to the TGA
    • Information or documents
    • Recall and public notification powers unaffected
    • Powers to suspend or cancel goods from the ARTG unaffected
    • Enforceable undertaking
    • Injunction
    • Infringement notice
    • Revocation or suspension of manufacturing licence
    • Civil penalty provisions
    • Criminal offences
    • Publication of compliance or enforcement outcomes
  • GMP Compliance case studies
    • Suspension of EDQM Certificate of Suitability (CEP)
    • Anonymous Tip-off
    • USFDA Warning Letter
    • Hazard alerts for missing donor related medical history

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