GMP evidence is required for manufacture of a medicine or an Active Pharmaceutical Ingredient (API) used in a medicine, intended for supply in Australia. Evidence to demonstrate GMP compliance for product registration purposes for overseas sites can be done via the GMP clearance desktop pathway.
This guidance aims to assist sponsors when using the code tables for GMP Clearance applications by providing:
information regarding validation rules within the various product registration or listing systems.
Please note, the guidance is not intended for:
clarification of dosage forms or their validation in registration/listing systems
clarification of manufacturing steps or dosage forms for GMP licences for Australian manufacturing sites
biologicals, human blood and blood components and Haematopoietic Progenitor Cells (HPCs). Australia has its own manufacturing standard for these product types. However, where the manufacturing site performs only sterilisation of these product types, this guidance may be used.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.