An important part of Good Manufacturing Practice (GMP) is keeping records.
There are also legislated record-keeping requirements for Australian manufacturers [Regulation 20(i)], who need to keep records showing:
the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials
the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods
details of the tests performed on the goods and the results of those tests
the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods
We would expect overseas manufacturers to keep these records too.
Retain these records at the premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods [Regulation 20(iii)]. However, please check the code of GMP to see if the record keeping requirements are longer than this.
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.