Guidance on release for supply
For medicinal product manufacturers
Release for supply is a mandatory step in manufacture, in which the last manufacturer in the supply chain certifies each batch of medicines produced, before being released to the Australian market. This is to ensure that batch has been produced and quality controlled in compliance with all requirements under the Therapeutic Goods Act 1989.
This guidance document, which was developed in consultation with the industry, is published by the TGA to provide industry with guidance on release for supply of medicines. The guidance document consists of two parts:
- Part 1: Provides guidance on the general requirements applicable to all manufacturers and sponsors; and
- Part 2: provides examples of how the general requirements described in Part 1 can be met for specific areas of manufacture (for example, complementary medicines or sunscreens, or for different supply chains).