Manufacturing blood, tissues & biologicals

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This section is for manufacturers of blood, tissues and biological products. You should also see 'Manufacturing basics' which includes information for manufacturers of all types of therapeutic goods.

Revised code of GMP for human blood and tissues
The Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 commences on 31 May 2013
Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products
Applies to blood, human tissues and human cellular therapy products manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of human blood and blood components, human tissues and human cellular therapy products
Current standards applicable to TGA-licensed HPC manufacturers
Following a number of queries, and in relation to evaluation of Technical Master Files (TMF), the TGA would like to provide clarification regarding the product standards that apply to haematopoietic progenitor cells (HPCs).
Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
Describes the scope, detail and depth of information required for Technical Master Files to demonstrate the safety and quality of blood, blood components and haematopoietic progenitor cells
Guidance on licensing/certification inspections
The TGA performs inspections of Australian manufacturers of therapeutic goods to ensure that they meet an acceptable standard of GMP or comply with QMS standards

Web page last updated: Tuesday, 21 May 2013

URL: http://www.tga.gov.au/industry/manuf-btb.htm

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