Presentations given by the TGA Office of Manufacturing Quality
**These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which they relate. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health and Ageing (of which the TGA is a division) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation papers.**
Update to the Manufacturing Principles for Medicinal Products
December 2009
Presentation: Update to the Manufacturing Principles for Medicinal Products (pdf,473kb)
Presented by:
- Michel Lok, Head of the Office of Manufacturing Quality
- Mark Dickson, Medicines Audit Manager (Melbourne)
- Doug Fenwick, Medicines Audit Manager (Sydney)
- Gary Lane, Auditor (Brisbane)
- Robyn Oatey, Auditor (Adelaide)
Presented at: various seminars, Oct-Dec 2009
In July 2010, the TGA will adopt the PIC/S Guide to Good Manufacturing Practices for Medicinal Products as the applicable Code of GMP under Manufacturing Principles determined under Section 36 of the Therapeutic Goods Act 1989. The adoption reflects TGA's intention to maintain standards in line with international best practice.
A series of seminars were arranged in cooperation with professional associations to provide industry with an introduction to the major changes introduced in the PIC/S Guide and how the TGA would interpret and implement the new requirements. There was also an opportunity to answer any questions of concern. The seminars were held at the following venues:
- PDA Australia, Etihad Stadium Melbourne, 20 October 2009
- RACI Pharmaceutical Science Group (NSW), Ryde-Eastwood Leagues Club, 9 November 2009
- ISPE Australiasia Affiliate, Francis Rush Centre Brisbane, 18 November 2009
- ISPE Australiasia Affiliate, BioSA Incubator Conference Centre Adelaide, 8 December 2009
The seminars were very well attended with more than 250 attendees in Sydney and Melbourne, and around 70 in both Brisbane and Adelaide.
Ensuring efficient & effective GMP compliance (in challenging times)
14 September 2009
Presentation: Ensuring efficient & effective GMP compliance (in challenging times) (pdf,328kb)
Presented by: Michel Lok, Head of the Office of Manufacturing Quality
Presented at: ISPE Australasia Conference, Sydney, 13-15 September 2009
The 2009 ISPE Australasia conference involved workshops and presentations in three themes - facilities, process and project management; operational excellence and compliance. The TGA provided two presentations to the conference.
Ensuring efficient and effective Good Manufacturing Practice (GMP) compliance in challenging times examined the expectations of the various government, consumer and industry stakeholders and outlined key elements of an effective GMP compliance program. The presentation assesses five risks and challenges (the global financial crisis; achieving consistency; overseas manufacturing; new technologies and securing the supply chain) and how TGA was tackling these within a risk management framework.
Changes to manufacturing standards, implementation of Quality Risk Management and other TGA program updates
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15 September 2009
Presented by: Noel Fraser, Training Manager and Auditor, Office of Manufacturing Quality
Presented at: ISPE Australasia Conference, Sydney, 13-15 September 2009
The 2009 ISPE Australasia conference involved workshops and presentations in three themes - facilities, process and project management; operational excellence and compliance. The TGA provided two presentations to the conference.
In July 2009 the TGA announced the update of its Manufacturing Principles, adopting the internationally harmonised PIC/S Guide to GMP for Medicinal Products. The new requirements will become mandatory from July 2010. The presentation outlines the major changes to GMP requirements in Australia and the TGA's plans for implementation of quality risk management practices. The presentation also notes other changes planned within the manufacturing quality program.
Manufacturing quality program - Proposed cGMP human tissues
5 May 2009
Presentation: Manufacturing Quality Program: Proposed cGMP Human Tissues (pdf,163kb)
Presented by: Michel Lok, Head of the Office of Manufacturing Quality
Presented at: Australian Tissue and Biotherapeutics Forum Scientific and Business Meeting, Perth, 5 May 2009
The presentation provides a summary of the TGA's licensing program for tissue banks and outlines the development of a proposed revision to the Code of Good Manufacturing Practice for Human Tissues.
Quality risk management - TGA perspective
April/May 2009
Presentation: Risk Management - TGA perspective (pdf,116kb)
Presented by: Anthony Gould, Chief GMP Auditor, Office of Manufacturing Quality (Melbourne) and Mark Dickson, Manager, Medicine Audit and Clearance Team, Office of Manufacturing Quality (Sydney)
Presented at: PDA seminar, Melbourne, Tuesday 21 April 2009, and RACI seminar, Sydney, Wednesday 27 May 2009
The seminar program also included presentations on QRM applications in the food industry and in the pharmaceutical industry by other speakers. For the implementation of the 2009 code of Good Manufacturing Practice, Quality Risk Management is expected to be integrated into the Quality System of pharmaceutical companies. It is anticipated that an Aide Memoire on the Assessment of Quality Risk Management Implementation will be published by PIC/S in the first quarter of 2010 to further assist both auditors and industry with this requirement.
The TGA and process analytical technology
17 February 2009
Presentation: The TGA and Process Analytical Technology (pdf,94kb)
Presented by: D Fenwick, Medicines Audit Team Manager, Office of Manufacturing Quality
Presented at: ARCS seminar "Process Analytical Technology - the new manufacturing paradigm?", Tuesday 17 February 2009
The seminar program included presentations on Process Analytical Technology (PAT) applications in the food industry and in the pharmaceutical industry. The presentation provides an overview of two overseas regulators' (U.S. FDA and EMEA) approaches in relation to PAT in the pharmaceutical industry, the TGA's current approach and some broad expectations for companies implementing PAT initiatives. The presentation is provided for informational purposes only and is not intended to define specific requirements for regulatory submissions or for achieving compliance to manufacturing standards for PAT implementations.