Good Manufacturing Practice (GMP)

The TGA have recently adopted the guidelines of GMP, as established by the Pharmaceutical Inspection Co-operation Scheme (PIC/S), as the new Australian Code of GMP. The Australian Code of GMP is a set of procedures and principles which, when followed by manufacturers of therapeutic and veterinary goods, help ensure appropriate quality standards are met.

Typically all manufacturers of therapeutic and veterinary goods must follow a set quality standard of manufacturing principles and procedures to ensure consistency in product quality, safety and efficacy. The TGA requires non-exempted Australian and overseas manufacturers to hold a License to Manufacture Therapeutic Goods. The APVMA requires manufacturers of veterinary chemical products to also comply with the manufacturing principles. ChemSkill has the expertise to develop procedures on the behalf of or assist manufacturers in compliance with the requirements of GMP.