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

Responsibilities:

Manufacturer

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