What GMP means when you outsource supplement manufacturing
What Good Manufacturing Practice (GMP) means in practice when a contract manufacturer makes your supplement or listed medicine, and what records to expect.
Good Manufacturing Practice (GMP) is a set of quality standards that controls how medicines are made, so every batch matches its specification. In Australia, manufacturers of listed medicines are licensed and inspected by the TGA against its GMP requirements.
What GMP looks like on the floor
Written procedures for each step, followed and signed off
Qualified, maintained equipment
Controlled production areas and cleaning between products
Raw material checks before use
Batch records that trace every batch from materials to finished pack
Testing and formal release before a batch leaves the site
What it means for you as a brand
GMP gives you documented evidence of how each batch was made. Expect batch documentation and release records, and a clear process for raising and resolving issues.
GMP at DB Pharmaceuticals
We manufacture under a TGA GMP licence at our Kings Park facility. See our quality approach.
This guide is general information only. It is not regulatory or legal advice, and requirements change. Check current requirements with the TGA or a qualified regulatory consultant before making decisions about your product.