Audit feedback forms (pilot)

5 February 2015

Following consultations with industry associations, the Manufacturing Quality Branch is undertaking a pilot project to seek manufacturers' feedback following TGA audits. The feedback will be used to improve audit procedures and training.

Audit feedback forms

Feedback received through these forms will not be handled as complaints, though will be treated confidentially where requested.

How to access a pdf or Word document

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.

Audit feedback form - routine

The 'Audit feedback form - routine' allows manufacturers to comment on the planning, conduct and communication of manufacturing audits. Manufacturers will be encouraged to complete a form following each audit undertaken.

Audit feedback form - interpretation of requirements

The 'Audit feedback form - interpretation of requirements' is intended for use on those occasions where a manufacturer has a different view concerning the interpretation of a Code of GMP or an international standard made by an auditor(s). Feedback received will be investigated and used to monitor consistency of interpretation of manufacturing requirements and for staff training purposes.

Complaint procedure

The MQB aims to resolve complaints informally wherever possible, however, more serious concerns should be made in writing and be directed to the Head of Branch, Manufacturing Quality Branch.

More information: Manufacturing Quality Branch complaint process

To return your feedback

Feedback forms can be returned in any of the following ways:

Post: Head of Branch
Manufacturing Quality Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Australia
Email: gmp@tga.gov.au (with "Audit Feedback Form" in the email subject)
Fax: +61 2 6232 8426