Last week, Bob Tribe, who is an Executive Consultant with PharmOut spent the week in Riyadh, Saudi Arabia assisting the GMP Inspections Section of the Saudi FDA get ready to lodge an application for PIC/S membership. This involved a review of the systems and procedures of the GMP Inspections Section, including its Quality System, against the membership requirements for PIC/S. It also involved observing a typical GMP inspection in Buraydah, Saudi Arabia (approx. 300 km north of Riyadh in a desert region and famous for growing dates).
The Saudi Food and Drug Authority (SFDA) website indicates that the SFDA was established under the Council of Ministers, as an independent body corporate that directly reports to The President of Council of Ministers. The objective of the Authority is to ensure safety of food and drug for man and animal, and safety of biological and chemical substance as well as electronic products. The main purpose of the SFDA establishment is to “regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured”.
Bob consults to many GMP regulatory authorities around the world, assisting them reach the PIC/S level of regulatory control. To date, he has assisted the Health authorities of South Africa, Israel, Cyprus, Ukraine, Indonesia, Taiwan, South Korea, Hong Kong and Thailand in obtaining their PIC/S membership. He is currently assisting the regulatory authorities of Iran, Turkey, Nigeria, Saudi Arabia, Vietnam and Philippines with their preparations for PIC/S membership.
Bob works frequently in developing countries, supporting their efforts to establish safe and compliant pharmaceutical manufacturing facilities.