Australian codes of good manufacturing practice - current status
31 July 2009
Set out below are the various manufacturing standards, specified in the Therapeutic Goods Act 1989 as Manufacturing Principles, for different categories of therapeutic goods (except for medical devices) as regulated by the TGA.
For medical devices subject to conformity assessment procedures, see Chapter 4 of the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical devices) Regulations 2002, and Australian Guidelines for Medical Devices.1
| Product Category | Manufacturing Standard |
|---|---|
| Active Pharmaceutical Ingredients |
ICH Harmonised Tripartite Guideline - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - 10 November 20001 (Applicable to all Australian manufacturers of APIs and to overseas manufacturers of prescription medicines evaluated by the Drugs Safety and Evaluation Branch of the TGA) From July 2010: PIC/S Guide for Good Manufacturing Practice for Medicinal Products - 15 January 2009 |
| Medicinal Products |
Australian Code of GMP for Medicinal Products - 16 August 20021 From July 2010: PIC/S Guide for Good Manufacturing Practice for Medicinal Products - 15 January 2009 |
| Sunscreen Products |
Australian Code of GMP for Sunscreen Products - February 19942 From July 2010: PIC/S Guide for Good Manufacturing Practice for Medicinal Products - 15 January 2009 |
| Human Blood and Tissues | Australian Code of GMP for Human Blood and Tissues - 24 August 20001 |
| Other therapeutic devices listed on the ARTG | ISO 13485:1996 or ISO 13488:19963 |
| Other therapeutic devices registered on the ARTG | ISO 13485:19963 |
Availability of documents
- TGA website
- TGA Information Officer
- PO Box 100, Woden ACT 2606, Australia;
- email: info@tga.gov.au
- Standards Australia
- PO Box 1055, Strathfield NSW 2135, Australia;
- website: http://www.standards.com.au
Content last updated: Friday, 31 July 2009
Content last reviewed: Friday, 31 July 2009
Web page last updated: Tuesday, 3 May 2011
URL: http://www.tga.gov.au/industry/manuf-cgmp-status.htm