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TGA webinar presentation: Good Manufacturing Practice (GMP) clearance applications - common pitfalls, 6 December 2019

13 December 2019

Disclaimer

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.

Presentation

  • Presented by: Karman Leung
  • Presented at: Online webinar
  • Presentation date: 6 December 2019
  • Presentation summary: Overview of process and evidence submitted for the GMP Clearance application process, commonly identified issues and ways to improve application quality. The presentation provides information on the common deifiencies identified at both receipting and assessment stage, including how to reduce common errors which may result in unnecessary delays or ineffective applications.