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TIWGG Technical Working Groups

TGA-Industry Working Group on Good Manufacturing Practice

10 December 2020

Under the terms of reference of TIWGG, Technical Working Groups (TWGs) may be established to develop, consider and review GMP guidelines and related issues for specific medicine classes or processes.

Every TIWGG meeting includes a standing agenda item, which provides updates on the work of these TWGs.

TWG composition

The TWGs are small groups that bring together expertise on particular aspects of GMP. Each TWG has representatives from:

  • the TGA Manufacturing Quality Branch, one of which will chair the TWG
  • other relevant TGA branches
  • relevant external parties and where possible industry associations.

Industry representatives are appointed with agreement between the TGA and external stakeholders to ensure that the various members of each TWG have areas of expertise that complement each other. The appointment process for a position to be filled is:

  • the relevant industry association nominates at least two candidates and provides their resumé demonstrating GMP expertise
  • the TGA indicates its preference, based on the areas of expertise already represented
  • the TGA and the stakeholder reach agreement on the preferred candidate.

External parties represented on TWGs

Complementary medicine manufacturing TWG

  • Consumer Healthcare Products (CHP) Australia
  • Complementary Medicines Australia (CMA)
  • MedSafe

Release for supply processes TWG

  • Accord
  • Australia New Zealand Industrial Gas Association (ANZIGA)
  • Consumer Healthcare Products (CHP) Australia
  • Complementary Medicines Australia (CMA)
  • Medicines Australia (MA)

Radiopharmaceuticals TWG

  • Australian Nuclear Science and Technology Organisation (ANSTO)
  • Cyclotek (Aust) Pty Ltd
  • Global Medical Solutions Australia Pty Ltd
  • Metro North Hospital and Health Service T/A Royal Brisbane & Women's Hospital
  • SLHD Royal Prince Alfred Hospital Department of PET & Nuclear Medicine
  • South Australian Health & Medical Research Institute Ltd

Sunscreens TWG

  • Accord
  • Consumer Healthcare Products (CHP) Australia

Contact details for TWGs

TWGs can be contacted through the TIWGG secretariat.