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Tech Alert: Update to the GMP approach to overseas manufacturers during the COVID-19 Pandemic

02 Nov 2021 10:23 AM | Anonymous member (Administrator)

Following collaboration with the TGA-Industry Working Group on GMP (TIWGG), the TGA have provided an update on certain temporary measures introduced last year for overseas manufacturers. 

Today's tech alert provides information on the latest update and includes details for sponsors and manufacturers on the following and requests any feedback to CMA through our ongoing participation on TIWGG:

- Ongoing use of Remote Inspections.

- Compliance verification pathway.

- Mutual Recognition Agreement (MRA) pathway.

- Remote GMP Inspections.

- GMP clearance

- Fees and charges associated with inspection and GMP clearance processes.

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