TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG)

Role of the TIWGG

The TIWGG was established in 2014 to facilitate consultation between the TGA and the therapeutic goods industry on matters relating to good manufacturing practice (GMP). The TIWGG will also provide a mechanism for TGA to seek comments from industry on the revision, development and application of guidelines which support adoption and implementation of the PIC/S GMP Guide.

The TIWGG is a consultative forum, not a management or advisory committee. Although the TIWGG may make recommendations or propose solutions on particular matters, the TGA will be the decision maker on whether or not to accept the recommendations or implement the proposed solutions. Where recommendations or proposed solutions are not accepted by TGA, an explanation will be provided.

Given the broad membership, the TIWGG is intended to consider and discuss matters that are applicable across industry sectors. Where industry sector-specific matters arise, these can be addressed by Technical Working Groups.

Terms of Reference

The Terms of Reference (ToR) of the TIWGG are:

• To prioritise and discuss issues of a regulatory and technical nature arising from current regulation and propose solutions where required
• To determine the need for establishing Technical Working Groups (TWGs) to develop:
  • new, or review existing guidelines
  • comments on draft PIC/S guidelines for tabling by TGA at PIC/S meetings
  • GMP related guidance documents
  • guidelines on how TGA will apply PIC/S guidelines to take into account issues specific to the Australian market and/or specific product types
• Oversight the work of TWGs including making decisions on when the work of a TWG has been completed
• To provide a forum for members to raise regulatory, technical or business process issues of concern, both current and emerging, faced by the TGA, the representative associations or members of the manufacturing community generally
• To provide a forum for the TGA and members to invite guests to speak on topics that are within these ToR or applicable to the broader regulatory framework
• To inform parties about the TGA’s present and future activities relating to GMP.

These Terms of Reference will be reviewed as required.

TIWGG membership

Chair

The Chair of TIWGG is the Assistant Secretary, Manufacturing Quality Branch (MQB), TGA. The Chair may also co-opt TGA managers and other industry representatives or relevant experts as required.

Members

The TIWGG is stakeholder representational group comprising members nominated by the peak industry associations representing the manufacturers of therapeutic goods, as follows:

• Accord
• Active Pharmaceutical Ingredient Manufacturer’s Association of Australia (APIMAA)
• Association of Therapeutic Goods Consultants Inc (ATGC)
• Australia and New Zealand Region of International Society of Cell and Gene Therapy (ISCT)
• Australia New Zealand Industrial Gas Association (ANZIGA)
• Australian Red Cross Lifeblood (Lifeblood)
• Biotherapeutics Association of Australasia (BAA)
• Complementary Medicines Australia (CMA)
• Consumer Healthcare Products (CHP) Australia
• Generic and Biosimilar Medicines Association (GBMA)
• Medicinal Cannabis Industry Association (MCIA)
• Medicines Australia (MA)

Meetings

TIWGG meetings are usually held three (3) times a year in Canberra. However, due to the COVID-19 situation, meetings have been more frequent and held by teleconference / video conferencing. See TIWGG meeting summaries.

TIWGG Technical Working Groups

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. For further information on TWGs, see TIWGG Technical Working Groups.

Contact details for TIWGG