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C6A: Release for Supply (Batch Certification) – Meeting your Obligations as an Authorised Person

Tracks
Goldfields Theatre Breakout 1
Wednesday, November 20, 2024
11:00 AM - 11:30 AM

Details

Annex 16 is a new Annex as part of the PIC/S guide to GMP version 16 called “Certification by the Authorised Person and Batch Release” which was adopted in Australia on 2 September 2024. This session will provide an overview of the new Annex delving into the differences between a Qualified Person and Authorised Person and what requirements and expectations exist when performing the confirmation and/or certification functions. Examples and case studies from GMP inspections will be discussed to illustrate the principles from Annex 16 and how departure from these can lead to deficiencies being raised.

Speaker: Jenny Hantzinikolas, Director, Inspections Section

Jenny Hantzinikolas is the Director of the Inspections Section in the Manufacturing Quality Branch in TGA. She has a degree in Biochemistry and Microbiology. She leads a team of Inspectors who inspect medicines and blood and biological products manufacturers within Australia and overseas. She has been with the TGA for 20 years and was in industry for 17 years. Her experience in industry was in mostly bacterial and viral vaccines and also some experience in oral and topical non sterile medicines.

Speaker: Gaye Camm, Senior GMP Inspector, Inspections Section

Gaye is a Senior GMP Inspector within the Manufacturing Quality Branch. They have an Honours Chemistry degree and 30+ years working within TGA as both an analytical chemist and GMP Inspector. Gaye is a technical specialist for GMP related to manufacture of listed and complementary medicines, medicinal cannabis, sunscreens and medical gases, and GMP related to QC testing and management of laboratory electronic data capture systems. Gaye currently co-chairs the TGA-Industry Working Group on GMP for Complementary and Listed Medicines.

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