Update on Good Manufacturing Practice (GMP) and PIC/S in the Asia Pacific Region

GMP regulations and guidelines in the Asia Pacific region are changing rapidly. A number of countries within the region have gained accession to PIC/S or are working towards this; however other countries within the region, notably China maintain their own requirements. These differences can be problematic to manufacturers, particularly when transferring manufacture into the region.This presentation will review the current status of PIC/S accession and approval of markets within the Asia Pacific region and discuss the harmonisation efforts of ASEAN and other regional initiatives. It will also review recent and proposed changes to GMP regulations in major markets. While there is rapid change occurring and a general move towards PIC/S style GMP, some marked differences remain in the way GMP is applied across the region which may present challenges to companies seeking to set up local manufacture in or source product from the region. We will discuss some of these key challenges.Delegates will gain an understanding of: Current GMP developments within the Asia Pacific region, issues which may be encountered in particular markets, the potential direction and impact of GMP regulations in key regional markets.