Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe

Technical working groups

17 December 2013

Technical Working Groups (TWG) have been established by the TGA to bring together manufacturing technical expertise from industry and the regulator to address any areas of the relevant manufacturing standards that may need further interpretation or guidance.

Several guidance documents for medicines manufacture  have been developed through the technical working groups. These are, together with other guidance documents, available at Technical guidance on the interpretation of manufacturing standards.

TWG terms of reference

The technical working groups help to build consistency in manufacturer inspections and standards of operation.

Technical working groups:

  • provide technical governance
  • provide expert advice to the TGA in relation to key aspects of GMP and quality management system (QMS) inspection business
  • conduct regular information sessions/forums with relevant stakeholders including industry peak bodies and associations to ensure that effective consultation occurs before any key policy changes are implemented.

TWG composition

The technical working groups are small groups which bring together expertise on particular aspects of GMP and QMS. Each technical working group has representatives from:

  • the TGA Office of Manufacturing Quality (OMQ), one of which will chair the TWG
  • other relevant TGA Offices
  • relevant external parties, where possible industry associations

Industry representatives are appointed in agreement between the TGA and 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 and/or QMS 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.

Technical working groups have been established for the following subject areas:

Technical Working Groups can be contacted through their chairpersons at the Office of Manufacturing Quality using the TGA manufacturing contact details.

Top of page

Blood tissue & cellular therapy (BT&CT) technical working group

  • TGA Office of Manufacturing Quality (OMQ), chair
  • TGA Office of Scientific Evaluation (OSE) - Biological science section

External parties represented:

  • The Australian Red Cross Blood Service
  • New Zealand Blood Service
  • Lions Corneal Donation Service/East Melbourne
  • Institute of Medical & Veterinary Science/SA Tissue Bank
  • Victorian Institute of Forensic Medicine/Donor Tissue Bank of Victoria.

Complementary medicine technical working group

  • TGA Office of Manufacturing Quality (OMQ), chair
  • TGA Office of Complementary Medicines (OCM)

External parties represented:

  • Complementary Healthcare Council (CHC)
  • Australian Self Medication Industry (ASMI).

Top of page

Medical device technical working group

  • TGA Office of Manufacturing Quality (OMQ), chair
  • TGA Office of Devices Authorisation

External parties represented:

  • Australian Dental Industry Association
  • Medical Industry Association of Australia Inc.
  • AusBiotech.

Non-sterile medicine technical working group

  • TGA Office of Manufacturing Quality (OMQ), chair
  • TGA Office of Medicines Authorisation (OMA) - OTC Medicines evaluation section

External parties represented:

  • Australian Self Medication Industry Association (ASMI)
  • Medicines Australia
  • Generic Medicines Industry Association (GMIA).

Pharmacy manufacturing technical working group

  • TGA Office of Manufacturing Quality (OMQ), chair
  • Other TGA Offices as required

External parties represented:

  • PCCA Australia
  • Pharmaceutical Compounding NZ Ltd
  • Australasian Compounding Association
  • Baxter Healthcare Pty Ltd,
  • Council of Pharmacy Registering Authorities Inc.
  • Pharmaceutical Society of Australia
  • Richard Stenlake Compounding Chemist
  • The Pharmacy Guild of Australia
  • Society of Hospital Pharmacists of Australia.

Sterile medicine technical working group

  • TGA Office of Manufacturing Quality (OMQ), chair
  • TGA Office of Laboratories and Scientific Services - Microbiology section

External parties represented:

  • Medicines Australia
  • Generic Medicines Industry Association (GMIA).

Radiopharmaceuticals sub-group to the sterile medicine technical working group

  • TGA Office of Manufacturing Quality (OMQ), chair
  • TGA Office of Laboratories and Scientific Services - Microbiology section

External parties represented:

  • Australian Radiation Protection And Nuclear Safety Agency (ARPANSA)
  • Australian Nuclear Science and Technology Organisation (ANSTO)
  • Society of Hospital Pharmacists of Australia
  • Cyclotek (Aust) Pty Ltd
  • GMS Australia Pty Ltd
  • Cyclopharm Ltd

Top of page

Content last updated: Tuesday, 17 December 2013

Content last reviewed: Tuesday, 17 December 2013

Web page last updated: Wednesday, 18 December 2013

URL: http://www.tga.gov.au/industry/manuf-twg.htm