Manufacturing guidance covering medicinal gases, qualification, and validation processes is being considered under two concept papers released for public consultation, according to the Therapeutic Goods Administration (TGA).
The consultation process forms part of broader international work led by the Pharmaceutical Inspection Co?operation Scheme (PIC/S) to update good manufacturing practice (GMP) expectations in line with current industry approaches.
The first concept paper proposes a limited revision of Annex 6 of the PIC/S GMP Guide, which covers the manufacture of medicinal gases.
The proposed update aims to reflect modern industry practices, including the increased use of new technologies and computerised systems in manufacturing environments.
The TGA noted that Annex 6 is adopted under Australia’s Manufacturing Principles, and Australian manufacturers are encouraged to review the concept paper and provide feedback during the consultation period running from 11 February to 11 April 2026.
The second consultation focuses on proposed revisions to Annex 15 of the GMP Guide, which covers qualification and validation in manufacturing.
The concept paper seeks to expand the scope of Annex 15 to include active substance manufacturers and to consider alignment with the International Council for Harmonisation’s guideline on quality risk management, known as ICH Q9 (R1).
According to the TGA, the update is intended to support contemporary quality assurance approaches across manufacturing operations.
The TGA said the consultations provide an opportunity for industry stakeholders to contribute to the development of manufacturing guidance that reflects evolving technologies, risk management practices, and production standards.
Australian manufacturers are encouraged to review both concept papers and submit comments through the EU Survey tool links provided as part of the consultation process.
The consultation period for Annex 15 is open from 9 February to 9 April 2026, while feedback on the Annex 6 proposal can be submitted until 11 April 2026.
The regulator said comments on both documents should be directed through the designated online submission platform.
