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.**
Manufacturing quality program: The regulation of cellular therapies in Australia
23 May 2010
Presented by: Jeanette Ripper, GMP Auditor, Office of Manufacturing Quality
Presented at: 16th International Society for Cellular Therapy (ISCT) Annual Meeting (23-26 May, 2010) - Global Regulatory Perspectives Workshop, 23 May 2010, Philadelphia, Pennsylvania, USA
The presentation provides an overview of the current regulation of cellular therapies in Australia. It details the legislative requirements under which the TGA regulation of cell based therapies operates and the current standards applicable to haematopoietic progenitor cells (both cord blood derived and non-cord dervived HPCs). The requirements for the regulation of the manufacturing of cell based therapies, using the Australian code of GMP for Human Blood & Tissues, is discussed and examples of the requirements for compliance to the various sections of the code of GMP are discussed.
Manufacturing quality program and the proposed cGMP human blood, tissues & cellular therapies
30 April 2010
Presented by: Jeanette Ripper, GMP Auditor, Office of Manufacturing Quality
Presented at: The Fourth Margaret River Forum-Pathways toward Molecular and Cellular Therapy. International Society for Cellular Therapy (ISCT) - Regulatory Workshop, 30 April 2010, Margaret River, WA
The presentation provides a summary of the proposed regulation of cellular therapies under the New Biologicals Framework. The requirements for the regulation of the manufacturing of cell based therapies using the proposed new code of GMP are discussed. Examples of cGMP clauses specific to cellular therapies are highlighted.
New manufacturing principles and GCP initiatives
29 April 2010
Presentation: New manufacturing principles and GCP initiatives (pdf,288kb)
Presented by: Doug Fenwick, Medicines Audit Team Manager, Office of Manufacturing Quality
Presented at: The Association of Therapeutic Goods Consultants Conference, Thursday 29 April 2010
Summary of presentation: The presentation provides an overview of changes to the Manufacturing Principles relating to the adoption of the PIC/S Guide for Good Manufacturing Practice for Medicinal Products, January 2009 and some expectations for audit of manufacturers under the new standard. The presentation also included a brief overview of the Office of Manufacturing Quality's initiatives towards implementation of an audit program of Clinical Trials in accordance with Good Clinical Practice.
The presentation is provided for informational purposes only and is not intended to define specific requirements for achieving compliance to the PIC/S Guide for Good Manufacturing Practice for Medicinal Products.
Shelf life stability studies
28 April 2010
Presentation: Shelf life stability studies (pdf,215kb)
Presented by: G Camm, Medicines Auditor, Office of Manufacturing Quality
Presented at: This presentation was delivered to an event organised by CAPSIG (Cosmetics & Pharmaceuticals Special Interest Group), 28 April 2010
Summary of presentation: The presentation was provided to give cGMP perspectives on stability testing. It encompassed an overview of the Australian Regulatory Guidelines and the Australian Code of Good Manufacturing Practice for Medicinal Products (August 2002) in relation to stability testing. It also included considerations required for stability testing due to the changes to cGMP resulting from the adoption of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products - January 2009. A summary of audit aspects of stability programs and testing was included in the presentation.
Draft product quality review for Listed complementary medicines
26 March 2010
Presentation: Draft product quality review for Listed complementary medicines (pdf,128kb)
Presented by: Andrew Muir, GMP Auditor, Office of Manufacturing Quality
Presented at: CHC Upcoming Regulatory Changes in the Complementary Healthcare Industry Forum, Sydney 26 March 2010
Summary of presentation: The presentation provides an overview of a draft guidance document for product quality reviews for complementary medicines. The requirements of the PIC/S Guide to GMP for Medicinal Products for product quality reviews are discussed with reference to complementary medicines. The relevant responsibilities of sponsors and manufacturers are highlighted.
New manufacturing principles updating the Code of GMP - the impact on complementary medicines manufacture
25-26 March 2010
Presented by: Anton Norder, Technical & Development Manager, Office of Manufacturing Quality
Presented at: Complementary Healthcare Council Forum on Upcoming changes to the Complementary Medicines Industry, Sydney, 25 & 26 March 2010
Summary of presentation: The presentation provides background information as to why the Code of GMP was updated and what the main areas of change are for complementary medicines manufacturers and sponsors.
It also highlights the TGA's expectations and transition arrangements with regards to complementary medicines manufacture for the areas of Product Quality Review, Quality risk management, On-going stability testing and Reference and retention samples.
Manufacturing quality program - The Australian GMP requirements for bacterial contamination testing of cell and tissue products
25 March 2010
Presented by: Katherine Clark GMP Auditor, Office of Manufacturing Quality
Presented at: Biomerieux Cell and Tissue Therapies Forum, Melbourne, 25 March 2010
Summary of presentation: The presentation provides a summary of the current regulation of bacterial contamination testing for human cell and tissue products. The requirements for testing cell and tissue products and the applicable standards are discussed. Some common GMP issues are highlighted.
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
Summary of presentation: 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.