Commercial-in-Confidence

Audit Feedback Form - Routine

Notice
This form is intended to provide general feedback on the planning, conduct and communication of
routine audits undertaken by the TGA. The information received will be used to review processes
and for internal training.
Feedback received through this form will not be regarded as a complaint. Complaints should
be made in writing and addressed to the Head of Office, Office of Manufacturing Quality.
Privacy Information
The TGA collects your personal information in this form to provide context to your feedback. For
information about how your personal information is protected under the Privacy Act 1988 (Cth)
please go to Privacy.

Part 1: Manufacturer and Audit Details

Manufacturer

Address of
Manufacturing
Premises

Auditor(s)
Dates of Audit
Names

Name: ………………………………….. Signature: ……………………………………

Position: ……………………………….. Date: ………………….

The TGA thanks you for your feedback

PO Box 100 Woden ACT 2606 ABN 40 939 406 804

Phone: 1800 020 653 Fax: 02 6232 8605 Email: info@tga.gov.au www.tga.gov.au
Part 2: Before the Audit

1. Were you satisfied with the notice given for the dates of audit?

YES NO

2. Were you provided with an audit plan at the opening meeting?

YES NO

3. Was the purpose of the audit and the auditing process explained to you?

YES NO

Comments (add additional pages if required):

Part 3: Conducting the Audit

1. Were you satisfied with the amount of time allocated for the audit?

YES Not enough time Too much time

2. Was the audit organised in a logical manner?

YES NO

3. Were you provided with explanations by the auditors of their observations?

YES NO

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4. Were you provided sufficient opportunity to comment on the auditors observations?

YES NO

Comments (add additional pages if required):

Part 4: Completing the Audit

1. Was a list of items for discussion provided to you at the closing meeting?

YES NO

2. Were you provided enough opportunity to clarify and comment on audit findings?

YES NO

3. Were you informed about how to respond to the audit, how you can query audit
observations and how you can provide TGA with feedback?

YES NO

Comments:

** Add additional pages if required

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Part 5: The auditor(s)

1. Were the auditor(s) courteous and professional ?

YES NO

2. Do you consider that the auditor(s) demonstrated a sound understanding of the

Manufacturing Principles, Code of GMP (or international standards) and regulations?

YES NO

3. Did the auditors demonstrate an understanding of the products and/or manufacturing

processes undertaken at your manufacturing site?

YES NO

Comments (add additional pages if required):

Part 6: General comments

Comments (add additional pages if required):

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