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

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through the effective and timely regulation of therapeutic goods. The TGA is committed to consulting with its external stakeholders and its activities contribute towards the Department's delivery of its vision to provide better health and...

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through the effective and timely regulation of therapeutic goods. The TGA is committed to consulting with its external stakeholders and its activities contribute towards the Department's delivery of its vision to provide better health and wellbeing for all Australians, now and for future generations.

Role of the TIWGG

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

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 cut 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.
  • To determine the need for establishing a 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
    • 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 established by the TIWGG, including making decisions on when the work of a TWG has been completed.
  • To provide a forum for members to raise regulatory or technical issues of concern, both current and emerging, faced by the TGA, the representative associations or members of the manufacturing community generally.
  • To inform parties about TGA's present and future activities relating to GMP.

Membership

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.

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

  • Accord
  • Australia New Zealand Industrial Gas Association (ANZIGA)
  • Active Pharmaceutical Ingredient Manufacturer's Association of Australia (APIMAA)
  • Australian Self Medication Industry (ASMI)
  • Complementary Medicines Australia (CMA)
  • Generic and Biosimilar Medicines Association (GBMA)
  • Medicines Australia (MA).

2018 TIWGG meeting dates

Meeting no. Meeting dates
12 15 March
13 6 June
14 19 July
15 22 November

TIWGG meeting summaries

Following its establishment, the inaugural meeting of the TIWGG was held on 16 December 2014. The following meeting summaries are intended to provide high level information about the types of topics and issues which are considered by this consultative working group.

2018

2017

Source: www.tga.gov.au