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TGA presentation: How to submit an effective good manufacturing practice clearance application

29 October 2019


These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Jodie Giess, MDPQD MQ Clearance SN Section, MDPQD Manufacturing Quality Branch, Therapeutic Goods Administration (TGA)
  • Presented at: Online TGA webinar
  • Presentation date: 10 September 2019
  • Presentation summary: Overview of the GMP clearance application process, commonly identified issues and ways to improve application quality. The presentation provides information on how to submit an effective application, including how to reduce common errors, which may result in delays, ineffective clearances or the need to submit additional applications