In addition to TIWGG, Technical Working Groups (TWGs) have been 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.
Active TWGs
Complementary medicine manufacturing TWG
Scope:
- Advise the TIWGG on current guidelines applicable to manufacturers of complementary medicines.
- Identify and discuss key areas of concern relevant to the interpretation and application of PICS guidelines and explore options to address those concerns, while maintaining appropriate manufacturing standards.
- Provide technical/expert advice to the TIWGG on application of the PICS guidelines for complementary medicines.
External parties:
- Consumer Healthcare Products (CHP) Australia
- Complementary Medicines Australia (CMA)
- MedSafe
Inactive TWGs
Release for supply processes TWG
External parties:
- Accord
- Australia New Zealand Industrial Gas Association (ANZIGA)
- Consumer Healthcare Products (CHP) Australia
- Complementary Medicines Australia (CMA)
- Medicines Australia (MA)
Radiopharmaceuticals TWG
External parties:
- 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
External parties:
- Accord
- Consumer Healthcare Products (CHP) Australia
Contact details for TWGs
TWGs can be contacted through their chairperson using the TGA manufacturing contact details.