GMP Annex 6 and Annex 15 concept papers - Open for public consultation

Concept paper on the revision of Annex 6 - Manufacture of medicinal gases

The Pharmaceutical Inspection Co‑operation Scheme (PIC/S) have opened a public consultation on a concept paper proposing revisions to Annex 6 (Manufacture of medicinal gases) of the PIC/S Good Manufacturing Practice (GMP) Guide.

The proposed revision aims to undertake a limited update of the guideline to reflect current industry practices, including the use of new technologies and computerised systems. 

The TGA adopts Annex 6 as part of the Manufacturing Principles and encourages Australian manufacturers to review the concept paper and provide any feedback. The consultation is open from 11 February to 11 April 2026.

• Concept paper: PIC/S website
• Submit comments via the EU Survey tool 

Concept paper on the revision of Annex 15 - Qualification and validation

PIC/S have also launched a public consultation on a concept paper proposing revisions to Annex 15 (Qualification and validation) of the PIC/S GMP Guide.

The proposed revision seeks to extend the scope of Annex 15 to active substance manufacturers and to consider updates aligned with ICH Q9 (R1) on quality risk management. 

The TGA adopts Annex 15 as part of the Manufacturing Principles and encourages Australian manufacturers to review the concept paper and provide any feedback. 

The consultation is open from 9 February to 9 April 2026.

• Concept paper: PIC/S website
• Submit comments via the EU Survey tool

How to provide feedback

Comments on both concept papers should be submitted via the EU Survey tool links.