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Qudos - Helping with your compliance needs

August 2023

Educational Presentations & Information

TGA Presentation

Insights from the TGA Good Clinical Practice (GCP) Inspection Program

ICH Q3D – Elemental Impurities

A presentation from Prof Talks discussing sources of elemental impurities including incoming materials, equipment, and container closure systems.

Nitrile versus Latex Gloves

A presentation from ISPE Singapore about the differences between latex and nitrile gloves in a cleanroom environment.

Upcoming Events

Foodtech Packtech and Materials Handling and Logistics Expo

 

Foodtech Packtech (FTPT) is New Zealand’s largest food manufacturing, packaging and processing technology trade show.  This year they have combined with the Materials Handling & Logistics Expo, and are expecting 250+ local and international exhibiting companies.

 

Auckland Showgrounds

19-21 September 2023

News

August News
TGA

17/08/2023

Medicine Shortages

There are new reporting requirements for companies supplying medicines into Australia when their medicines are due to go into shortage.

After a six month grace period (from March 2023), Sponsors will be required to report:

  • Changes to the shortage duration or end date and resolution of the shortage.
  • The period of the shortage of the medicine in Australia.
  • Any changes to the period and resolution date of a medicine shortage where the medicine shortage period ends on or after 22 September 2023, regardless of when the shortage was first notified.

Medsafe

17/08/2023

Update to Guidelines on the Regulation of Therapeutic Products

The Guidelines on the Regulations of Therapeutic Goods (Manufacture of Medicines) has been updated to version 5.1.

August News