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ARGB Appendix 4 - Guidance on TGO 88
Australian Regulatory Guidelines for Biologicals (ARGB)
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- TGA website
- TGA approach to minimising the risk of exposure to TSEs
- WHO malaria information
- CDC malaria endemic area information
- Council of Europe 'Guide to the preparation, use and quality assurance of blood components, 14th edition'
- ISO (International organisation for standardization)
- Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
- EMEA guidance document Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (EMEA/410/01 rev 3, July 2011) (pdf,1Mb)
- EMEA guidance document Note for Guidance on Virus Validation Studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses Feb 1996 (pdf,53kb)
- Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation