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Revising the Code of GMP for blood and tissues

The Code of Good Manufacturing Practice and Therapeutic Goods Order for donor selection, testing and minimising infectious disease for blood, blood components, human tissues and human cellular therapy products

11 September 2012

The TGA is continuing to progress the revision of the Code of Good Manufacturing Practice for Blood and Tissues (August 2000). There will be a twelve month transition period from the current code once the revised Code of GMP is introduced.

Anticipated changes:

• a revised Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products
• a new Therapeutic Goods Order: Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products (Infectious Disease Minimisation standards).

Current code and guidance

Manufacturers need to continue to comply with:

• the current Code of GMP for blood and tissues-human blood and tissues (August 2000), which continues to apply to blood, blood components, tissues and cellular therapy products.

Sponsors preparing dossier content for biologicals applications are advised to consult:

• Appendix 4 of the Australian Regulatory Guidelines for Biologicals (ARGB): Guidance on donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products. This reflects the current position of the TGA, which was reached after extensive public consultation and committee-endorsement.

Sponsors and manufacturers are advised to contact the TGA with questions regarding infectious disease minimisation requirements.