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Good Manufacturing Practice annual report 2019-20

30 November 2020
Download Good Manufacturing Practice annual report 2019-20

Description

The GMP (Good Manufacturing Practice) annual report highlights regulatory activities, stakeholder engagement, international regulatory engagement, compliance, and improvements to our regulatory requirements to meet our objectives under the TGA's Business Plan for 2019-20.

Our team is focused on making sure therapeutic goods supplied in Australia from domestic and international manufacturers meet specified standards and manufacturing principles. This is done through risk-based inspection and desk-top assessment programs.

During the 2019–20 financial year, the TGA:

  • Received 778 applications for the GMP licences and certificates
  • Conducted a total of 214 GMP inspections
  • Completed 7051 GMP clearance desktop inspections
  • What we do
  • Highlights
  • Ensuring manufacturing quality
  • GMP licensing and certification
  • Inspections
  • Compliance
  • GMP Clearance
  • Business improvement and education
  • International collaboration
  • New GMP requirements for medicinal products
  • Good Clinical Practice pilot inspection program
  • Stakeholder engagement
  • Responding to COVID-19

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