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Inspection and audit feedback forms
The TGA's inspection of therapeutic goods manufacturers operates within a Quality Management System. We welcome feedback in relation to the conduct of inspections, and will ensure that TGA continuously improve our training and management systems.
The terms 'inspection' and 'inspector' are synonymous with the terms 'audit' and 'auditor' used by the Medical Devices Surveillance Branch.
The feedback information will be used to improve inspection procedures and training given by the TGA.
Feedback received through these forms will not be handled as complaints, though will be treated confidentially where requested.
These forms are available in pdf and Microsoft Word formats. The pdf forms can be filled in and saved to your computer using Adobe Reader version 7 or later, or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader, you can fill in the form on-screen and print it out, but you will not be able to save the completed form.
Inspection feedback form - routine
The 'Inspection feedback form - routine' allows manufacturers to comment on the planning, conduct and communication of inspections. Manufacturers will be encouraged to complete a form following each inspection and provide constructive feedback (both positive feedback and areas that need improvement).
- Inspection feedback form - routine (pdf,172kb)
- Inspection feedback form - routine (Microsoft Word,137kb)
Inspection feedback form - interpretation of requirements
The 'Inspection feedback form - interpretation of requirements' is intended for use when a manufacturer has a different view concerning the interpretation of the Code of GMP, an international standard, or demonstrating compliance with an Essential Principle made by an inspector(s). Feedback received will be reviewed, assessed and used to monitor consistency of interpretation of manufacturing requirements, and for staff training purposes.
- Inspection feedback form - interpretation of requirements (pdf,114kb)
- Inspection feedback form - interpretation of requirements (Microsoft Word,134kb)
The TGA aims to resolve complaints informally wherever possible; however, more serious concerns should be made in writing and be directed to:
- Medicines: Assistant Secretary, Manufacturing Quality Branch
- Medical devices: Assistant Secretary, Medical Devices Surveillance Branch
- For GMP inspections: Inspections and inspectors - the complaint process
- For device audits: Certification audits for medical devices
To return your feedback
Return your feedback by email to:
For GMP inspections:
Please include 'inspection feedback form' in the subject line.
For device audits:
Please include 'audit feedback form' in the subject line