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Our 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.
Note
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.
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: 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.
Complaint procedure
We aim 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
More information:
- For GMP inspections: Inspections and inspectors: the complaint process
- For device audits: Certification audits for medical devices
Returning your feedback
Return your feedback by email to:
For GMP inspections:
Include 'inspection feedback form' in the subject line.
For device audits:
Include 'audit feedback form' in the subject line