The current Therapeutic Goods (Manufacturing Principles) Determination specifies that manufacturing of medicinal products in Australia must meet the PIC/S Guide to GMP – 25 August 2023, PE009-17, 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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Regulatory decision noticesFrom 1 September 2025, the TGA will adopt an updated version of the PIC/S Guide to GMP (PE009-17), with changes focused on Annex 1 for sterile medicines, and a phased compliance approach for manufacturers.
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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.
The PIC/S Guide to GMP for medicinal products – version 17
From 1 September 2025 the PIC/S Guide to GMP – 25 August 2023, PE009-17 will apply to the manufacture of medicines, active pharmaceutical ingredients and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989 (the Act).
The Guide is divided into two parts with 20 annexes.
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Overview of the guide’s purpose and structure for harmonised GMP standards.
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GMP requirements for manufacturing finished medicinal products.
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GMP principles for producing active pharmaceutical ingredients (APIs).
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Additional guidance for specialised manufacturing processes.
Page history
Updated information to reflect the latest version of the PIC/S Guide to GMP – 25 August 2023, PE009-17, except for Annexes 4, 5 and 14 on 1 September 2025.
Updated information to reflect the latest version of the PIC/S Guide to GMP – 25 August 2023, PE009-17, except for Annexes 4, 5 and 14 on 1 September 2025.