Record keeping requirements for manufacturers of medicines

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.

For more details go to:

• Responsibilities of manufacturers of medicines and biologicals
• Chapter 4 in PE009, the PIC/S guide to GMP for medicinal products.