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

3 October 2017

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

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
  • 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).

2017 TIWGG meeting dates

Meeting no. Meeting dates
9 16 March
10 20 July
11 23 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.

Topics discussed included –

  • the review of the regulation of low risk therapeutic goods
  • TGA PIC/S re-assessment
  • Publication of MQB data on the TGA website
  • Oversight of the Crisis Management Guidelines and Product Contamination & Extortion Protocol
  • GMP Clearance updates including the GMP Clearance interim solution, GMP Clearance Guidance, the Clearance Application Assistance Tool (CAAT), the proposed CV strategy, the GMP Clearance Roadshow and the Licensing & Certification Guidance document
  • an update on the adoption of the PIC/S Guide
  • the inaugural Industry Forum on GMP

TIWGG also welcomed an informative presentation from the TGA on the EC – PIC/S differences in approach to the regulation of advanced therapy medicinal products (ATMP) and a second, informative presentation from MTP Connect.

Topics discussed included –

  • the review of the regulation of low risk therapeutic goods
  • an update from the February 2017 PIC/S Committee of Officials Meeting
  • current and future updates to PIC/S Guide (including  Annex 1 revision timelines)
  • the Licensing and Certification Guidance Document and various GMP Clearance Issues
  • a proposed plan for adoption of the PIC/S Guide
  • a proposal to host an inaugural GMP Annual Industry Forum
  • a proposal concerning E-signatures on GMP Licences and Certificates

TIWGG also welcomed an informative presentation from MTP Connect (the MedTech and Pharma Growth Centre).

Topics discussed included –

  • various GMP Clearance Issues including the development of a new e-form and associated workflow
  • the consultation process for revisions to the PIC/S Guide
  • the GMP standard for medicinal cannabis
  • the likelihood of impact of the Medicines and Medical Devices Review (MMDR) reforms on MQB
  • current and future updates to the PIC/S Guide
  • consultation on the PIC/S gap analysis: Version 9 vs Version 13
  • consultation on an ISO Standard gap analysis - ISO14644:2015 (Part 1 and 2) Cleanrooms and associated controlled environments
  • PIC/S Guidance on Data Integrity
  • Australian implications for European API inspection requirements
  • TGA hosting of an API PIC/S Expert Circle Meeting
  • status of the revised Uniform Recall Procedure for Therapeutic Goods

TIWGG also welcomed informative presentations from the TGA regarding progress with implementing the Government's Response to the MMDR; and also from the Office of Best Practice Regulation (OBPR) which provided an overview of OBPR's work and the regulatory impact analysis process.

Topics discussed included –

  • structural changes within the Department of Health, including the TGA
  • an update from the July 2016 PIC/S Committee of Officials Meeting
  • the PIC/S Guide consultation process
  • revision and adoption of the PIC/S Guide
  • revision of the GMP Clearance Guideline
  • revision of the Licensing and Certification Guideline
  • an update on the Business Process Review of GMP Clearances
  • an MQB compliance update
  • an update on the inspection close-out process
  • reinspection frequencies update
  • MQB Metrics (Inspections and Recalls Sections)
  • an update on the TGA Business Improvement Program

Topics discussed included –

  • the PIC/S Guide consultation process
  • an update from MQB's Recalls Section
  • an update on the TGA Business Improvement Program
  • discussion of TGO78 – Standard for tablets and capsules
  • an update on the Business Process Review of GMP Clearances
  • an update on the inspection close-out process
  • an MQB compliance update
  • the publishing of TIWGG Minutes or meeting summaries

Topics discussed included -

  • advice that the second part of the Report on the Review of Medicines and Medical Devices Regulation had been published but implementation of the recommendations was yet to be agreed by government
  • an update on the future consultation of the revision of Annex 1 of the PIC/S Guide
  • revision and adoption of the PIC/S Guide
  • consultation on the revision of Annexe 13 and 17 of the PIC/S Guide
  • an update on the TGA Business Improvement Program
  • an update on the Business Process Review of GMP Clearances
  • TIWGG's operations and 2016 priorities

Topics discussed included –

  • advice that the second part of the Report on the Review of Medicines and Medical Devices Regulation and the Department of Health's Functional Efficiency Review had not yet been released by government
  • an update on the future consultation of the revision of Annex 1 of the PIC/S Guide
  • an update on the TGA Business Improvement Program
  • an update on the revised inspection close-out process
  • revision and adoption of the PIC/S Guide
  • an update on the Business Process Review of GMP Clearances

Topics discussed included –

  • advice that the government is now considering the first Report on the Review of Medicines and Medical Devices Regulation and the Department of Health's Functional Efficiency Review
  • the TGA's key focus on international harmonisation activities
  • an update on the review of the GMP Clearance process
  • an update from the May 2015 PIC/S Committee of Officials Meeting
  • the revised GMP inspection close out process
  • TGA actions in response to overseas regulatory actions

Topics discussed included –

  • the internal Business Process Review of the Manufacturing Quality Branch (MQB)
  • an update on the Review of the Regulation of Medicines and Medical Devices in Australia
  • an update on the Department of Health's Functional Efficiency Review
  • the Guideline on Release for Supply for medicinal products for manufacturers
  • a consultation mechanism for revision and adoption of the PIC/S Guide
  • ARTG entries with lapsed GMP Clearances
  • communication channels for GMP information
  • review of the TGA's GMP Clearance process

TIWGG also welcomed an informative presentation from the TGA on the revision of the TGA Compliance Risk Framework.

Topics discussed included –

  • the government's consideration of its deregulation agenda
  • the Productivity Commission's report on reducing unnecessary regulatory burden on industry and a Regulator Performance Framework
  • TIWGG's Terms of Reference and operating processes
  • TIWGG's Technical Working Groups (TWGs)
  • adoption of the PIC/S Guide to GMP for Medicinal Products ("PIC/S Guide")
  • the GMP Clearance application process
  • the PIC/S recommended model for risk based inspection planning in the GMP environment

TIWGG Technical Working Groups

In addition to TIWGG, three Technical Working Groups (TWGs) comprising TGA and industry subject matter experts have been established to develop, consider and review GMP guidelines and related issues specific to sunscreens, complementary medicines and release for supply processes. Every TIWGG meeting includes a standing agenda item which provides updates on the work of these three TWGs.

Further information

Meeting summaries are now made publicly available after each meeting.

For further information on the TIWGG, please contact the TIWGG Secretary by email craig.davies@health.gov.au

Contact details for TIWGG

Email
Phone +61 2 6232 8641
Postal Address TGA - Industry Working Group on GMP
Manufacturing Quality Branch
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606
Australia