TIWGG meeting summaries

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TIWGG member updates
  • New quality standards for MDMA and psilocybine have been registered on the Federal Register of Legislation. The consultation paper and outcomes paper are available on the TGA Consultation Hub.
• Inspections
  • MQB provided an update on the implementation of Surveillance Inspections.
• Release for supply
  • The Technical Working Group discussions on the expectations for the information required for an Authorised Person (AP) to release a batch are continuing.
• Reforms
  • Updates were provided on the Recall Reforms Program
• GMP Forum: 19-20 November 2024
  • The next GMP Forum will be held in Melbourne from 19 – 20 November 2024. The program has now been finalised and is available on the Forum's website.

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TIWGG member updates
  • The HPRG Digital Transformation Branch presented on the progress of the digital transformation work. The focus is to deliver robust digital platforms that will improve user’s experience.
  • TIWGG members provided updates on existing workloads and priorities, areas of focus as well as ongoing challenges.
• GMP resources
  • Information on how TGA regulates is available on the TGA Learn website pages.
• Release for supply
  • The Technical Working Group, including industry and TGA representatives, is reviewing the guidance document for greater clarity on the responsibilities of the Authorised Person.
• Inspections
  • Surveillance Inspections (SI) were discussed. This new inspection type is planned to reduce the existing inspection backlog and introduces reduced duration inspections that retain the same scope.
  • Announcement of the pilot GMP Single Inspection Program (SIP) with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada. This pilot originated from the PIC/S Inspection Reliance Working Group (IRWG) chaired by TGA.
• Reforms
  • Updates were provided on the various reforms underway in MQB particularly around the adoption of PIC/S version 16, MDMA and psilocybin, Recalls and GMP Clearance.

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TIWGG member updates
  • MQB provided an overview of the PIC/S Committee of Officials meeting, November 2023 in Bangkok Thailand, including noting that China has moved from ‘pre-applicant’ to ‘applicant’ status seeking membership of PIC/S.
  • TIWGG members provided updates on existing workloads and priorities, areas of focus as well as ongoing challenges.
• Release For Supply
  • Discussion held on the importance of the Release for Supply step of manufacture and the responsibilities of the Authorised Person (AP). TGA noted that this would be a focus during GMP inspections and clearance assessments.
• GMP Clearance
  • Several initiatives to be delivered by the end of 2023 including publication of the GMP Clearance Sponsor Information Dashboard (SID) and new updated guidance documents on the TGA website. Bulgaria will be added to the MRA pathway and the automatic extension of over 450 GMP Clearance applications expiring on 31 December 2023
• GMP Inspections
  • A case study was presented which demonstrated the challenges faced by MQB’s inspection co-ordination team and inspectorate when repeated requests for rescheduling or unexpected cancellations occur.
  • Surveillance inspection (same scope with reduced duration and less depth) is being considered by TGA to reduce inspection backlog.
• Reforms
  • Updates were provided on the various reforms underway in MQB particularly around MDMA and psilocybin, Recalls and GMP Clearance
• GMP Forum 2024
  • Preliminary planning has commenced for the next GMP forum, tentatively proposed as a two-day event in November 2024. Discussion held on the opportunity and benefit of aligning the November TIWGG meeting to coincide with the event.

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TIWGG member updates
  • TGA advised of internal restructuring to create the new GMP Operations and Strategy Section (GOSS); availability of enforcement actions and infringement notices issued are available on the TGA website, PIC/S activities update, recalls for pholcodine-containing medicines and five additional countries that have been added to EU AUS MRA
  • Industry Members provided updates and highlighted topics of interest, including clarification on the timeframes for inspections and close-out reports
• Significant numbers of unexpected cancellations and repeated requests for rescheduling of inspections. Members noted the possible reasons for this and possible mitigation strategies were proposed for further discussion within TIWGG
• GMP Forum 2023 debrief – there was strong positive feedback from surveys although there was need for some improvements in logistics (registration and invoicing processes)

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TIWGG member updates
  • MQB Sections provided updates on their current work. The Chair reflected on progress made on many fronts during 2022 – introduction of medicinal cannabis quality requirements, Recall Reforms Program, move back to onsite inspections, integration of remote inspections, managing approach to GMP clearances in an environment of reduced inspections by partner agencies.
  • Industry Members provided updates and highlighted topics of interest. These included noting the large number of consultations for 2022 and the need for adequate time to provide feedback, clarifications on ICMRA pilot on joint GMP inspections and use of hybrid inspections.
• Update from active Technical Working Groups
  • An update on work being conducted by the Complementary Medicines Technical Working Group (CM-TWG) was presented. Topics discussed included listed medicines, API premixes and expected requirements around the control of potential nitrosamine contamination in listed medicines, updates to the MQB Supplier Qualification and Sampling and Testing guidance documents and CM-TWG future work plans.
• A presentation on GMP clearance processes.
• A presentation on compliance framework and use of enforcement actions.

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TIWGG member updates
  • MQB Sections provided updates on their current work. Some of the Branch’s major focus areas are the continued response to COVID 19, improving processes for the return to onsite overseas inspections and medicinal cannabis reforms. The Recalls Section had been busy with recall actions arising from post market reviews of rapid antigen test (RAT) kits and surgical face masks.
  • Industry Members provided updates and highlighted topics of interest. These included medicinal cannabis reforms and the decision making process on on-site or remote inspection (both domestic and overseas).
• TIWGG work plan for 2022
  • Discussion regarding topics for future 2022 TIWGG meetings:
    • Continued updates regarding return to onsite inspections
    • Adoption and updates of PIC/S GMP - routine item
    • Ongoing education - topics and concerns from industry to assist in identification of target education materials and approaches
    • Education on the different mechanisms available to support clearance application
    • Sub working groups - review the status of sub working groups and scope of their activities. Members would like to receive updates from the sub working groups
• GMP forum 2023
  • The next GMP forum will be a face-to-face event to be held in Sydney in March 2023.

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TIWGG member updates
  • MQB Sections provided updates on their current work. The Branch’s major focus is the continued response to COVID, reviewing processes for the return to onsite inspections (domestic and overseas), recall reforms and medicinal cannabis reforms.
  • Industry Members provided updates and highlighted topics of interest. These included medicinal cannabis reforms, and TGA inspections (remote/hybrid/onsite).
• TIWGG work plan for 2022
  • Discussion regarding topics for future 2022 TIWGG meetings:
    • Continued updates regarding return to onsite inspections.
    • Adoption and updates of PIC/S GMP – routine item.
    • Ongoing education – topics and concerns from industry to assist in identification of target education materials and approaches.
    • GMP forum – Discussion regarding forum dates and identification of topics.
    • Sub working groups – review the status of sub working groups and scope of their activities.
• MRA COVID-19 Update
  • The TGA created a risk-based decision process allowing extended validities on GMP clearances via the MRA pathway. The clearance section has processed a large number of applications for GMP clearances that were expiring on 31 December 2021.

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TWIGG member updates
  • MQB Sections provided updates on their current work. The Branch’s major focus is the continued response to COVID, reviewing processes for the return to onsite inspections (domestic and overseas) and medicinal cannabis reforms.
  • Industry Members provided updates and highlighted topics of interest. These included medicinal cannabis reforms, implementation of ICH Q12 Technical and regulatory considerations for pharmaceutical products lifecycle management, TGA inspections (remote/hybrid/onsite) and MHRA’s consultation paper on products for point of care.
• Internal communication overview
  • In response to a previous request for information on internal TGA processes relating to GMP, a presentation was given that included an overview of when GMP clearances/licences are required for market authorisation applications. It highlighted that depending on the product type and category, GMP evidence is required either before submission or parallel with the product evaluation.
• Discussion on dissemination of TIWGG information
  • After discussion, it has been agreed that formal meeting minutes should not be disseminated outside the Group but TIWGG members can share agendas and their own notes with their organisation. Names of individuals attending the meetings and any agenda item so identified must remain confidential.
  • For greater transparency, some additional information will be included in the meeting summaries published on the TGA website.
• Preliminary discussion of TIWGG work plan for 2022
  • The first meeting of 2022 will be used to discuss and confirm the TIWGG's workplan for the year. Members were requested to ask their respective associations to identify possible topics.
• Medicinal cannabis reform
  • The TGA updated members on the progress of the reforms. Main activity is working with the Office of Best Practice Regulation (OBPR) to determine if a Regulation Impact Statement (RIS) is required.

Topics discussed included -

• Review of Action items from previous meetings
• MQB Section and TWIGG member updates
• Accessibility of existing GMP education material and resources
• PIC/s guide to GMP version 15 update
• GMP Clearance approach during pandemic
• Presentations to Members in relation to Medicines Scheduling, GMP Forum Feedback and TGA Digital Transformation

Topics discussed included -

• Review of Action items from previous meetings
• COVID-19: Discussion and updates
• MQB Section and TWIGG member updates
• TGA Digital Transformation update
• Presentations to Members in relation to the Consultation on options for the enhancement or redevelopment of TGA Recalls Database and Remote / Hybrid inspections in the future

Topics discussed included -

• Review of Action items from previous meetings
• COVID-19: Discussion and Updates
• GMP Forum updates
• GMP Compliance guidance introduction
• MQB Section and TIWGG member updates
• MQB 2020 - Operational review industry feedback
• Discussion with members about future TIWGG meetings

Topics discussed included -

• Review of Action items from previous meetings
• COVID-19: Discussion and Updates
• MQB Section and TIWGG member updates, including annual performance reporting
• Discussion with members about GMP Forum 2021 (virtual event)
• Future topics for TIWGG meetings

Topics discussed included -

• Review of Action items from previous meetings
• COVID-19: Discussion and Updates
• Review of the MQB Operating Model - Updates
• Agreed to invite Association of Therapeutic Goods Consultants Inc (ATGC) to working group
• TIWGG Secretariat transition

Topics discussed included -

• Review of Action items from previous meetings
• COVID-19: Discussion and Updates
• Review of the MQB Operating Model - Discussion with mpconsulting

Topics discussed included -

• COVID-19: Discussion and Updates
• Review of MQB Operating Model
• PIC/S GMP Guide Version 14 - Gap Analysis update

Topics discussed included -

• MQB General Updates - Good Clinical Practice (GCP) Pilot Program, Consultation on Sports Supplements, New Recalls Web Form and the release of Version 2.2 of the Uniform Recall Procedure for Therapeutic Goods (URPTG)
• COVID-19: Discussion and Updates
• GMP Clearance extensions during COVID-19

Topics discussed included -

• General MQB Update
• Adoption of PIC/S GMP Guide PE009-13 - progress update on trends
• Feedback from the consultation on PIC/S GMP Guide PE009-14
• PIC/S Update - PIC/S Working Groups and consultations in progress
• Risk Based Inspection (RBI) programme - "other" risk category
• MQB Section Updates
• MQB Performance Reporting Updates
• Publication of MQB Data on the TGA Website
• 2019 GMP Forum Update
• Industry updates on current issues
• Digital Transformation - What opportunities may exist for industry if TGA improves its digital interface?
• Update on Faecal Microbiota Transplantation
• Technical Working Groups updates

Topics discussed included -

• General MQB Update
• Adoption of PIC/S GMP Guide PE009-13 - progress update on trends
• Feedback from the consultation on PIC/S GMP Guide PE009-14
• PIC/S Update - PIC/S Working Groups and other matters
• GMP Clearance Update
• Licensing and Certification Update
• Good Clinical Practice (GCP) Inspections Program - Update
• MQB Performance Reporting
• 2019 GMP Forum Update
• Industry updates on current issues
• Future horizons and emerging trends - autologous biological products, faecal microbiota transplantation and other
• Technical Working Groups updates

Topics discussed included -

• GMP Service Delivery in TGA - progress update
• Review of guidance documents as a result of PIC/S Guide PE009-13 - progress update
• Adoption of PIC/S GMP Guide PE009-13 - progress update
• PIC/S Update - Working Groups and other matters
• Updates on current industry issues
• Publication of MQB data on TGA website
• Good Clinical Practice (GCP) Inspections Program public consultation - presentation and discussion
• GMP Clearance Update
• Licensing and Certification Update
• MQB Performance Reporting
• 2019 GMP Forum
• Revision of PIC/S GMP Guide PE009-14 - gap analysis
• Technical Working Group updates

Topics discussed included -

• Update from the PIC/S Committee of Officials meeting, held September 2018
• GMP Service Delivery in TGA - progress update
• Sunsetting of the Therapeutic Goods (TG) Regulations, TG Medical Devices Regulations and TG Charges Regulations
• Review of guidance documents as a result of PIC/S Guide PE009-13
• Adoption of PIC/S GMP Guide PE009-13 - progress update
• PIC/S Update - Working Groups and other matter
• Operationalisation of API MRA with Health Canada
• Updates on current industry issues
• Proposal to establish a Prescription Medicines Technical Working Group
• Australian implications for European API inspection requirements
• GMP Clearance Update
• Discussion on GMP Clearance Processes
• Licensing and Certification Update
• MQB Performance Reporting
• Uniform Recall Procedure for Therapeutic Goods (URPTG) - matters regarding interpretation
• 2019 GMP Forum
• Revised TIWGG Terms of Reference
• Revision of PIC/S GMP Guide PE009-14
• Presentations on recent changes to the Medicines Shortages program and recent TGA Regulatory Education initiatives
• Technical Working Group updates
• 2019 meeting dates

Topics discussed included -

• publication of MQB data on the TGA website
• 2018 GMP Forum wrap-up
• Review of guidance documents as a result of PIC/S Guide PE009-13
• Adoption of PIC/S Guide PE009-13 - progress update
• PIC/S Update - Working Groups and other matters
• GMP Service Delivery in TGA - Meeting 13 review
• updates on current industry issues
• GMP Clearance Update
• Licensing and Certification Update
• TIWGG Membership - requests for expansion
• Uniform Recall Procedure for Therapeutic Goods (URPTG) - matters regarding interpretation
• Technical Working Group updates

Meeting 13 was a special meeting convened by teleconference to specifically commence discussions on further GMP Service Delivery in the TGA.

This followed the significant 2017 business improvements and initiatives which have generally been positively received by industry stakeholders. Ongoing feedback from TIWGG members in relation to opportunities to improve the performance and delivery of MQB's work program has been welcomed and TIWGG will continue to be utilised as the primary consultative mechanism to achieve this.

Members were invited to provide advice on new priority issues which are of significance to their industry sectors. These issues were considered by TIWGG and an agreed list of priority business improvement issues has been established.

While the overall aim is to deliver solutions as soon as possible, there will be a need to carefully prioritise the issues to ensure both, MQB and TIWGG members can deliver viable outcomes with their available resources.

Topics discussed included -

• MRA issued GMP certificates of sites outside the auditing bodies' borders
• publication of MQB data on the TGA website
• updates on current industry issues
• GMP Clearance updates
• GMP related fees and charges
• Operationalisation of API MRA with Health Canada
• sunsetting of the Therapeutic Goods (TG) Regulations and TG Charges Regulations
• hosting of the 2018 GMP Forum on 26 June 2018
• update on the new Uniform Recall Procedure for Therapeutic Goods (URPTG)
• Technical Working Group updates

Topics discussed included -

• structural changes within the Department of Health
• outcomes from the TGA's PIC/S re-assessment
• publication of MQB data on the TGA website
• an update from the 2017 PIC/S API Expert Circle meeting
• feedback from stakeholders on MQB's GMP Clearance initiatives (e-forms, guidance, CATT and CV strategy)
• GMP Clearance updates
• GMP Certificates and statements of compliance
• GMP related fees and charges
• sunsetting of the Therapeutic Goods (TG) Regulations and TG Charges Regulations
• adoption of the PIC/S GMP Guide
• hosting of the GMP Annual Industry Forum
• publication of the new Uniform Recall Procedure for Therapeutic Goods (URPTG)
• Technical Working Group updates

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