Good Supplier Practice
The sourcing of starting materials for the manufacture of
medicinal products through local agents and suppliers is an area of
risk ASMI members have identified in the Australian environment
which is not comprehensively regulated by the TGA or State and
Territory Health Departments. The States and Territories only
license wholesalers handling scheduled substances, who must comply
with Good Wholesaling Practice (GWP). The TGA only
license wholesalers who conduct steps of manufacturer for active
substances who must comply with Good Manufacturing Practice (GMP). The
assurance of the quality of all starting materials; actives
(scheduled and unscheduled), excipients and packaging (printed and
unprinted), used in the manufacture of therapeutic goods rests with
the product manufacturer under the principles of GMP.
The medicine manufacturing industry in Australia places a strong reliance on local 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 the introduction of this industry guideline members of ASMI had been individually applying internal company standards to maintain their compliance with GMP, auditing suppliers and providing these suppliers with company specific qualification questionnaires for completion.
Members identified that a single agreed industry standard for Good 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.
Good Supplier Practice: An Industry Guideline (GSP) was launched in 2012 provides transparency of the expected standard of quality management for local agents and suppliers, along with provision of a shared suite of Vendor Qualification Questionnaires (VQQ). ASMI developed and maintain the VQQs in collaboration with Complementary Medicines Australia (CMA). We actively encourage members and non-members to utilise these standardised questionnaires.
A first year review of the ASMI GSP and the shared VQQ was undertaken in 2014. The Review Outcomes also included the provision of a rewritten TSE Questionnaire designed to reflect the updated TGA approach to minimising the risk of exposure.
The Industry Guideline:
- Good Supplier Practice: An Industry Guideline
- Supplier Vendor Qualification Questionnaire
- Raw Material Manufacturer Vendor Qualification Questionnaire
- Packaging Material Manufacturer Vendor Qualification Questionnaire
- Cover letter for Questionnaires
- Request for Change to Industry Guideline
For more information on the Industry Guideline: