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, nine 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 an Executive Consultant with PharmOut Pty. Ltd., Australia. He is also the ISPE Regulatory Affairs Advisor for the Asia-Pacific region.