Presentations about manufacturing therapeutic goods
19 December 2011
**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 it relates. 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.**
Validation and Qualification
8-9 December 2011
Presentation: Validation and Qualification (pdf,132kb)
Presentation by: Mark Dickson, Medicines Audit Team Manager, Office of Manufacturing Quality, TGA
Presentation at: National Validation Forum, Melbourne, 8-9 December 2011
Summary of presentation: TGA's expectations for validation and qualification of facility, equipment, processes and systems with an emphasis on a life cycle approach utilising quality risk management.
GMP audits
12-13 September 2011
Presentation: TGA's GMP Audits: Trends and observations (pdf,304kb)
Presentation by: Anton Norder, Quality & Technical Manager, Office of Manufacturing Quality, TGA
Presentation at: International Society of Pharmaceutical Engineers (ISPE) Melbourne Conference 12-13 September 2011
Summary of presentation: The presentation provides a summary of trends in OMQ's GMP audit program and details issues frequently identified as well as upcoming developments with regards to GMP.
Clinical trials
26 May 2011
- Presentation: Clinical trials, the TGA and GCP auditing (pdf,394kb)
Presented by: Josephine Dufty, Pharmacist, Experimental Products Section, TGA - Presentation: Clinical trial regulation in Australia - Good Clinical Practice audits (pdf,127kb)
Presented by: Katherine Clark, GMP Auditor, Office of Manufacturing Quality, TGA - Presentation: Answers to submitted questions (pdf,54kb)
Presented by: Katherine Clark, GMP Auditor, Office of Manufacturing Quality, TGA, and Josephine Dufty, Pharmacist, Experimental Products Section, TGA
Presented at: Sydney ARCS Scientific Congress 2011 'New Frontiers in Therapeutic Development and Usage', Randwick Sydney, 26 May 2011
Summary of presentation: These presentations provided a summary of the current regulation of clinical trials in Australia and the proposed electronic submission form. In addition, the clinical trial audit process was described and the procedures detailed. A number of questions submitted in advance of the presentation are also addressed.
This presentation is provided for informational purposes only and is not intended to define specific requirements for achieving compliance to the regulatory standards for the performance of clinical trials.
Release of therapeutic goods for supply in Australia
26 May 2011
Presentation: Release of therapeutic goods for supply in Australia (pdf,144kb)
Presented by: Doug Fenwick, Medicines Audit Team Manager, Office of Manufacturing Quality
Presented at: RACI seminar 'Release of Therapeutic Goods (Human and Vet) for Supply in Australia', 26 May 2011
Summary of presentation: The seminar program included presentations on Release for Supply of human and veterinary medicines by the TGA and APVMA respectively.
This presentation provides an overview of the requirements under the Manufacturing Principles for release for supply, the differentiation between release for sale and release for supply and of partially and fully finished products, the responsibilities of the parties involved, the assessment process and evidence used for release and the changes to the Manufacturing principles that have impacted on release for supply.
A number of Answers were provided to Questions received from participants prior to the seminar.
This 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 Release for Supply.
Quality risk management
4 May 2011
Presentation: Quality risk management (pdf,260kb)
Presented by: Matthew Davis, Lead Auditor, Office of Manufacturing Quality
Presented at: CAPSIG seminar 'Risk Management within Manufacturing Plants', 4 May 2011
Summary of presentation: This presentation provides an overview of the TGA's expectations regarding the implementation and application of Quality Risk Management. The presentation describes the milestones for implementation, key requirements of a Quality Risk Management system, areas of application, as well as examples of the audit process. Also included are some recent examples of deficiencies cited in relation to Quality Risk Management.
This 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 Quality Risk Management.
Content last updated: Monday, 19 December 2011
Content last reviewed: Monday, 19 December 2011
Web page last updated: Monday, 19 December 2011
URL: http://www.tga.gov.au/newsroom/events-presentations-manuf.htm