News about GMP/cGMP

14.12.2021

TGA: Hybrid and remote GMP-inspections

TGA: Hybrid and remote GMP-inspections

The Australian authority TGA has published a revision of the guideline on licenses and certification "Guidance on Australian manufacturing licenses and overseas good manufacturing practice (GMP) certification" on 1 December 2021. The revision relates to an expansion of possible inspection types as well as the scheduling of the inspection for licensing procedures.


Due to COVID-19, the form of inspections had to be aligned to the current pandemic containment regulations, which now allows not only on-site inspections, but also hybrid and remote inspections. The document is aimed at national drug manufacturers and overseas manufacturers producing for the Australian market. The guidance explains how inspections are assessed and what competencies are expected and what obligations must be met.

Manufacturers for or in Australia need to be aware of the timeframe for approval and certification processes.
It requires

  • up to 12 months for manufacturing licenses for an Australian-based company
  • and up to 15 months for GMP certifications for foreign manufacturers.

Source:

TGA: Hybride and remote inspections

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