PIC/s Guide to Good Manufacturing Practice (GMP): manufacturing principles for medicines, APIs and sunscreens

Newer version of PIC/S Guide to GMP

Section 36 of the Therapeutic Goods Act 1989 - external site (the Act) allows the Minister for Health and Aged Care to determine Manufacturing Principles - Therapeutic Goods (Manufacturing Principles) Determination - external site - that must be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients (API) and sunscreens, at Australian manufacturing sites. 

On 3 June 2024, the Determination was updated so that PIC/S Guide to GMP (01 February 2022), PE009-16 (PIC/S Guide to GMP version 16) applies. For therapeutic goods other than blood, blood components and biologicals, this means compliance with this guide, including the Annexes, other than:

• Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)
• Annex 5 (Manufacture of immunological veterinary medical products)
• Annex 14 (Manufacture of medicinal products derived from human blood or plasma). 

This update:

• doesn’t change the status of Annexes 4, 5 and 14
• includes clarifications to the existing Annex 13
• includes a new Annex 16 (Authorised person and batch release).

The guide applies to the manufacture of all medicines, APIs and sunscreens, unless exempt under provisions in the Act.

Transition period for Annex 16

Annex 16 will apply to therapeutic goods manufactured from 3 September 2024. 

The transition period from 3 June to 2 September 2024 allows manufacturers to assess and plan for any changes needed to comply with Annex 16.

Our expectation is that by 3 September 2024 manufacturers will have: 

• completed their assessment of the impact of the Annex 16 on their operations
• completed updating quality systems documentation and implementing revised practices 

Guidance on the changes

See our Good Manufacturing Practice (GMP) requirements for medicinal products: PIC/S Guide to GMP PE009-16 guide, which provides a summary of the new or amended requirements in the PIC/S Guide to GMP version 16.

How will deficiencies be reported?

We issue a post inspection letter at the conclusion of an inspection to communicate departures from GMP, with the purpose of assisting companies to restore compliance through root cause assessment and corrective actions.

During the transition period for Annex 16 we will be aiming to assist and encourage implementation of the new requirements. As a result, we will not cite a deficiency when companies demonstrate they are meeting the minimum expectations summarised above.

We will report a deficiency if the company has not undertaken an appropriate approach to implementing the new requirements or may not achieve compliance in a timely manner. This will usually be cited as an ‘other’ deficiency against the relevant part of the PIC/S Guide to GMP.

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly known as PIC/S) develops international standards to provide harmonised and constructive global co-operation in the field of GMP and related areas.

The purpose of PIC/S is to facilitate:

• networking between participating authorities 
• maintenance of mutual confidence
• exchange of information and experience
• mutual training of GMP inspectors.

We are a member of PIC/S.

For questions on these changes you can contact gmp@health.gov.au.