News about GMP/cGMP

12.11.2021

TGA continues use of remote inspections

TGA continues use of remote inspections

The Australian Therapeutic Goods Administration, TGA,  updated its GMP approach to overseas manufacturers of medicines and biologicals on 1 November 2021. With the COVID-pandemic still being an issue, TGA named remote inspections the only currently available option for certification applications.


What's new?

  • Sponsors with submitted applications will no longer be contacted prior to including them in the program.
  • Regarding alternative processes, TGA is still allowing manufacturers that had an on-site inspection in 2018/2019 to complete a GMP Clearance questionnaire to verify their compliance.

A prioritisation of inspections for overseas manufacturers will be based on:

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

Mutual Recognition Agreements, MRAs

  • TGA is liaising with regulatory partners worldwide and considers their range of approaches taken when it comes to remote GMP inspections. A large number of GMP clearances involving MRA partners will expire at the end of the year. Therefore, the most current evidence issued by MRA partners are accepted for both new and renewal applications.
  • Additionally, an extended validity of the GMP clearances will be gained for relevant new and renewal applications submitted and paid after 1 July 2021. TGA specifically mentions the European EMA and the EMA Guidance document as guidance and advice partner for this step.

Please find all necessary information on this topic on the corresponding TGA website.


Source:

TGA: On-going use of remote inspections

 


 

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