Manufacturing basics
Related information
- Good manufacturing practice for therapeutic goods
The term Good Manufacturing Practice is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality - Australian codes of good manufacturing practice - current status
Sets out various manufacturing standards, specified in the Therapeutic Goods Act 1989 as Manufacturing Principles, for different categories of therapeutic goods regulated by TGA, and likely future directions - Fit and proper persons requirements
Describes when sponsors/manufacturers should lodge a Fit and Proper Persons certification with the TGA - Risk based approach to audit frequency
The TGA has established a risk based approach to guide the scheduling of audits based on the compliance history of the manufacturer, the products made and the manufacturing processes undertaken - Enforcement guidelines
Describes and explains the enforcement provisions included in the Therapeutic Goods Act 1989, as introduced by the Therapeutic Goods Amendment Act (No.1) 2006 - Guidelines for sterility testing of therapeutic goods
Guidance for sterility testing of sterile therapeutic drugs and devices supplied in Australia for human use - Office of Manufacturing Quality complaint process
The TGA Office of Manufacturing Quality aims to resolve complaints informally wherever possible, however more serious concerns should be made in writing - PIC/S explanatory notes for pharmaceutical manufacturers on the preparation of a site master file
A Site Master File is a document prepared by a manufacturer to provide specific, factual information about the production and control of manufacturing operations at the named site, and any closely integrated operations in adjacent and nearby buildings - Technical working groups
Technical Working Groups have been established 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
Web page last updated: Wednesday, 6 April 2011
URL: http://www.tga.gov.au/industry/manuf-basics.htm