Good Supplier Practice

Members of ASMI have identified an area of risk in the Australian environment which is not currently addressed by TGA Guidelines, and that would benefit from the proactive implementation of an Industry Guideline: the sourcing of starting materials for the manufacture of medicinal products through local agents and suppliers.

The medicine manufacturing industry in Australia places a strong reliance on agents or suppliers to source starting materials, with minimum order constraints often limiting the ability of the industry to source directly from the overseas manufacturer of the material.

Until now members of ASMI have been individually applying internal company standards to maintain their compliance with GMP, auditing suppliers and providing these suppliers with documentation to be completed by the material manufacturers. Members identified that a single agreed industry standard for Supplier Practice would generate benefits to all parties in the starting material supply chain. They have therefore supported the development of a voluntary industry standard which they will apply to their agents/suppliers.