TGA: On-going use of Remote Inspections

Recommendation

Thursday, 2 May 2024 13.30 - 18.00 h

Excel in the GxP-regulated Environment - Live Online Training

Due to the ongoing pandemic, the Australian Therapeutic Goods Administration (TGA) had suspended its overseas GMP inspections. Like many other authorities, the TGA is currently working its way through a large number of certification applications. As international travel restrictions remain in place, the remote GMP inspection programme will continue, as the TGA currently notes on its website. This means remote inspections remain the only available option for certification applications during the pandemic. Now, sponsors with submitted applications for inspection will no longer be contacted individually.

Prioritisation of remote GMP inspections for overseas manufacturers will be based on the following criteria:

• the ability to use the alternative GMP Clearance processes
• current compliance information
• applications for marketing authorisation

What does this "GMP Clearance" mean?

The TGA is in contact with international partner authorities to understand the different approaches taken to GMP inspections. This information is evaluated and its implications for the TGA's own GMP clearance procedure are considered.

A Compliance Verification (CV) pathway is also in place for this purpose. Sponsors can still use the GMP clearance questionnaire for manufacturers who had an on-site inspection in 2018/2019.

It is important to note that inspection reports issued after a remote inspection or assessment are not accepted as primary evidence of GMP Clearance, i.e. they do not replace the inspection report of a physical on-site inspection.

If applicants have already used the questionnaire option for GMP Clearance, a TGA remote inspection will most likely be required for any further application.

To support industry, during the COVID 19 pandemic, the TGA introduced a temporary change to the documentation requirements for GMP Clearance applications submitted via the above Conformity Verification (CV) route.

To support a GMP Clearance application, applicants may submit a recently expired inspection report from a recognised regulatory authority and a GMP Clearance questionnaire, as well as any additional documents identified when completing the questionnaire. GMP Clearance applications are then evaluated using a risk-based approach.