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
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.