Australia TGA will conduct foreign site GMP audit every 2-3 years according to PIC/s guideline (http://www.picscheme.org). The GMP audit from Japan is conducted through submission of documents and are reviewed according to their GMP guidelines(PIC/S). Taiwan authority conduct GMP audit annually and the audit is based on Taiwan Chinese herbal medicine GMP guidelines.
In addition to the external GMP audits from the above health authorities, Sun Ten also conduct internal GMP audit every 6 months. There are internal and external GMP trainings for employees several times each year. |