The current Therapeutic Goods (Manufacturing Principles) Determination specifies that medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice (GMP) - 01 May 2021, PE009-15, except for its Annexes 4, 5 and 14 which are not adopted by Australia. Through the operation of section 36 and other provisions within the Act, the PIC/S Guide to GMP has legal force in Australia.
Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.
The PIC/S guide to GMP for medicinal products
The PIC/S Guide to GMP for medicinal products applies to all medicines (unless exempt under provisions in the Act). Interpretations of the PIC/S guide to GMP for medicinal gas manufacturers have been agreed by the TGA and the Australia New Zealand Industrial Gas Association.
- PIC/S Guide to GMP: Manufacturing principles for medicinal productsPublicationsPIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products, PE009-15, 01 May 2021: Current version
- Manufacturing principles & guidelinesPageTherapeutic Goods (Manufacturing Principles) Determination 2020.
Interpretative guidance
The following supporting documents are our interpretation and expectations for complying with the superseded version of the PIC/S guide to GMP (PE009-14).
They will be replaced with guidance for the current version of the PIC/S guide to GMP (PE009-15) once it is available.