The current Therapeutic Goods (Manufacturing Principles) Determination specifies that manufacturing of medicinal products in Australia must meet the PIC/S Guide to Good Manufacturing Practice (GMP) – 01 February 2022, PE009-16, except for its Annexes 4, 5 and 14 which are not adopted in Australia.
Through the operation of section 36 and other provisions of the Therapeutic Goods Act 1989 (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 the quality of therapeutic goods.
How the PIC/S guide to GMP for medicinal products applies
The PIC/S Guide to GMP for medicinal products applies to the manufacture of all medicines, active pharmaceutical ingredients and sunscreens, unless exempt under the Therapeutic Goods Regulations 1990.
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NewsAnnex 16 will apply to therapeutic goods manufactured from 3 September 2024. Find out about the transition period.
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GuidanceThis guidance explains good manufacturing practice (GMP) requirements for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens.
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PublicationsThis guide applies to the manufacture of medicines, active pharmaceutical ingredients and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989.
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The following supporting documents are our interpretation and expectations for complying with the superseded version of the PIC/S guide to GMP (PE009-14).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 (PE009-16) once it is available.