This presentation describes the various problem areas relating to GMP in the Asia Pacific region, particularly the various GMP problem areas that currently exist in India and China. The presentation also highlights the growing influence of PIC/S in Asia Pacific and how this influence will gradually help to improve GMP standards throughout Asia Pacific.
The growing influence of PIC/S in the Asia Pacific region will gradually help to improve GMP standards in the region over the next 5 years.
- Understand the main GMP problem areas in Asia Pacific.
- Understand the significant influence that PIC/S is having in the Asia Pacific region.
- Understand the current GMP requirements and regulatory guidance in countries like China, India, Australia, New Zealand, ASEAN group of countries, as well as PIC/S GMP requirements.
Bob Tribe joined the Therapeutic Goods Administration (TGA), Australia in 1971 as a GMP inspector after having worked in the pharmaceutical industry in a senior Quality Assurance position. He became Chief GMP Inspector in 1980, a position he held until his retirement in 2004. While at TGA he was elected Chairman of PIC/S in 2000-2001. After retiring from TGA he established “Bob Tribe Consulting” and has assisted many GMP regulatory authorities around the world reach the PIC/S level of regulatory control. Of the sixteen regulatory authorities that he has assisted to date, ten have obtained PIC/S membership. He also consults to pharmaceutical manufacturers wishing to achieve compliance with PIC/S GMP requirements. Bob is a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and undertakes GMP inspections for the WHO under its Pre-qualification Programme. Bob is the ISPE Regulatory Affairs Advisor for the Asia-Pacific region.