C1B: Complementary and Listed Medicines – GMP 101
Tracks
Eureka Room 2&3 Breakout 2
| Tuesday, November 19, 2024 |
| 10:30 AM - 11:00 AM |
Details
Complementary and listed medicines are considered lower risk medicines as they only contain pre-approved low risk ingredients and make low level health claims. However, poor manufacturing practise can result in substandard or contaminated product, which may not support the health claims being made by the product. Thus, compliance with standards of Good Manufacturing Practice is a cornerstone of TGAs risk-based regulation of these medicines.
In GMP 101 we will discuss the principle-based approach taken by the TGA-Industry Working Group on GMP for Complementary and Listed Medicines in formulating guidance documents for manufacture of these medicines. Recently updated sections of the PIC/S Guide will be in focus, such as implementation of Annex 16 for batch release, and control of starting materials, with a broader ranging review of the risk-based application of GMP.
Speaker: Gaye Camm, Senior GMP Inspector, Inspection 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.
In GMP 101 we will discuss the principle-based approach taken by the TGA-Industry Working Group on GMP for Complementary and Listed Medicines in formulating guidance documents for manufacture of these medicines. Recently updated sections of the PIC/S Guide will be in focus, such as implementation of Annex 16 for batch release, and control of starting materials, with a broader ranging review of the risk-based application of GMP.
Speaker: Gaye Camm, Senior GMP Inspector, Inspection 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.
