Complying with the PIC/S Guide to Good Manufacturing Practice (GMP) for medicinal products
Complying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
The current Therapeutic Goods (Manufacturing Principles) Determination - external site 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.