Technical working groups
7 June 2011
Technical Working Groups (TWG) have been established by the TGA's Office of Manufacturing Quality (OMQ) to bring together manufacturing technical expertise from industry and the regulator to address the grey areas or vagaries of the cGMP as it relates to manufacturing.
Terms of reference
- Provide technical governance and expertise on key areas of core GMP and QMS business for the TGA
- Consist of a small group to provide a solid platform to build audit consistency and standards of operation
- Provide OMQ's Audit Governance Committee (AGC) with advice in relation to key aspects of GMP and QMS audit business which will then be formally endorsed and uniformly implemented to ensure consistent interpretation and application of the various Manufacturing Principles (Codes of GMP) and standards of QMS by all TGA Auditors
- Have representation from other regulatory branches of the TGA as permanent members of each reference group
- Established for the following subject areas:
- Blood, Tissues and Cellular Therapies
- Complementary Medicines
- Medical Devices
- Non-Sterile Medicines
- Pharmacy Manufacturing
- Sterile Medicines
- Radiopharmaceuticals sub-group
- 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
Blood Tissue & Cellular Therapy (BT&CT) Technical Working Group
Current members
Chair
Ms Susanne Douglas
Office of Manufacturing Quality
Therapeutic Goods Administration
Members
- Ms Trisha Garrett
Office of Device Blood & Tissue
Therapeutic Goods Administration - Mr Glenn Smith
Office of Device Blood & Tissue
Therapeutic Goods Administration - Ms Vee Armstrong
The Australian Red Cross Blood Service - Ms Meredith Smith
New Zealand Blood Service - Mr Graeme Pollock
Lions Corneal Donation Service/East Melbourne - Mr Steven Nailer
Institute of Medical & Veterinary Science/SA Tissue Bank - Ms Kellie Hamilton
Victorian Institute of Forensic Medicine / Donor Tissue Bank of Victoria
Interpretive guides and documents
- Guides & documents will be available here as they become available.
Complementary Medicine Technical Working Group
Current members
Chair
Mr Andrew Muir
Office of Manufacturing Quality
Therapeutic Goods Administration
Members
- Ms Doreene Kohalmi
Office of Manufacturing Quality
Therapeutic Goods Administration
- Ms Hongxia Jin
Office of Complementary Medicines
Therapeutic Goods Administration - Mr Robert Watson
Complementary Healthcare Council - Ms Catherine Neuendorf
Australian Self Medication Industry - Ms Annette Ciprian
Natural Products NZ
Interpretive guides and documents
How to access a pdf or Word document
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On-going Stability Testing for Listed complementary medicines
This document provides guidance for the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products 2009 in relation to on-going stability testing for Listed Complementary Medicines. This guidance is not mandatory or enforceable under law.
- On-going Stability Testing for Listed complementary medicines (pdf,239kb)
- On-going Stability Testing for Listed complementary medicines (Microsoft Word,3.38Mb)
Product Quality Review for Listed complementary medicines
This document provides guidance for the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products 2009 in relation to product quality review for Listed Complementary Medicines. This guidance is not mandatory or enforceable under law.
- Product Quality Review for Listed complementary medicines (pdf,146kb)
- Product Quality Review for Listed complementary medicines (Microsoft Word,3.38Mb)
Process Validation for Listed complementary medicines
This document provides guidance for the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products 2009 in relation to process validation for Listed Complementary Medicines. This guidance is not mandatory or enforceable under law.
- Process Validation for Listed complementary medicines (pdf,138kb)
- Process Validation for Listed complementary medicines (Microsoft Word,3.38Mb)
Supplier qualification
This document provides guidance for the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products 2009 in relation to supplier qualification. This guidance is not mandatory or enforceable under law.
Sampling and testing of complementary medicines
- Sampling and testing of complementary medicines (pdf,171kb)
- Sampling and testing of complementary medicines (Microsoft Word,3.03Mb)
Medical Device Technical Working Group
Current members
Chair
Ms Dragana Milic
Office of Manufacturing Quality
Therapeutic Goods Administration
Members
- Mr Ray Cahill
Australian Dental Industry Association - Mr Greg Lauder
Medical Industry Association of Australia Inc - Mr Greg Roger
AusBiotech - To be advised
Office of Devices Blood & Tissue
Therapeutic Goods Administration
Interpretive guides and documents
- Guides & documents will be available here as they become available.
Non-Sterile Medicine Technical Working Group
Current members
Chair
Mr Gary Lane
Office of Manufacturing Quality
Therapeutic Goods Administration
Members
- Mr Greg Orders
Office of Manufacturing Quality
Therapeutic Goods Administration - Mr Raymond Wilson
Office of Non Prescription Medicines
Therapeutic Goods Administration - Mr Chris Oliver
Australian Self Medication Industry Association - Mr Graham Garside
Medicines Australia - Mr Brian Wood
Generic Medicines Industry Association
Interpretive guides and documents
- Guides & documents will be available here as they become available.
Pharmacy Manufacturing Technical Working Group
Current members
Chair
Mr Doug Fenwick
Office of Manufacturing Quality
Therapeutic Goods Administration
Members
- Ms Jenny Giam
PCCA Australia - Ms Lillian Handey
Pharmaceutical Compounding NZ Ltd - Mr John Mitchell
Australasian Compounding Association - Mr Greg Lauder
Baxter Healthcare Pty ltd - Mr Gerard McInerney
Council of Pharmacy Registering Authorities Inc - Mr Mark Feldschuh
Pharmaceutical Society of Australia - Dr Alan Hewitt
Richard Stenlake Compounding Chemist - Ms Margaret Joy
Project Officer, Therapeutic Goods Committee
Project Officer, National Coordinating Committee on Therapeutic Goods
Therapeutic Goods Administration - Mr Warren Lee
The Pharmacy Guild of Australia - Mr Kingsley Coulthard
Society of Hospital Pharmacists of Australia
Interpretive guides and documents
- Guides & documents will be available here as they become available.
Sterile Medicine Technical Working Group
Current members
Chair
Mr Stephen Hart
Office of Manufacturing Quality
Therapeutic Goods Administration
Members
- Mr Mark Dickson
Office of Manufacturing Quality
Therapeutic Goods Administration - Ms Kate Rusbridge
Microbiology Section
Office of Laboratories and Scientific Services
Therapeutic Goods Administration - Mr David Peacock
Medicines Australia - Mr Justin Daly
Generic Medicines Industry Association
Interpretive guides and documents
- Guides & documents will be available here as they become available.
Radiopharmaceuticals Sub-Group
Current members
Chair
Mr Anton Norder
Office of Manufacturing Quality
Therapeutic Goods Administration
Members
- Mr Mark Dickson
Office of Manufacturing Quality
Therapeutic Goods Administration - Ms Karen Longstaff
Microbiology Section
Office of Laboratories and Scientific Services
Therapeutic Goods Administration - Mr John Baldas
ARPANSA - Ms Sarah Ballantyne
ANSTO - Mr David Krenus
Cyclotek (Aust) Pty Ltd - Mr Mathew Farag
GMS Australia Pty Ltd - Mr Gordon Chan
Society of Hospital Pharmacists of Australia
Interpretive guides and documents
Guide to interpretation of the Code of GMP for the manufacture of 18-Fludeoxyglucose injections
This guidance is not mandatory or enforceable under law.
7 June 2011
The TGA has revised its Guide to interpretation of the Code of GMP for the manufacture of 18-FDG injections, to reflect the current Code of GMP. 18-FDG injections are a Positron Emission Tomography (PET) radiopharmaceutical product.
The revision of this Guide was prepared by the Radiopharmaceuticals sub-group of the Sterile Medicines Technical Working Group (TWG). This group seeks input from industry, hospitals and other interested parties to identify what it takes to expand the scope of this document to include other PET radiopharmaceuticals in the scope of this Guide.
If you are interested in providing any comments that might prove helpful in this matter, please email your input to anton.norder@tga.gov.au.
Content last updated: Tuesday, 7 June 2011
Content last reviewed: Tuesday, 5 April 2011
Web page last updated: Tuesday, 7 June 2011
URL: http://www.tga.gov.au/industry/manuf-twg.htm