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ARGB Appendix 4 - Guidance on TGO 88
Australian Regulatory Guidelines for Biologicals (ARGB)
Part 1 Introduction
Section 3 (of TGO 88) transition
TGO 88 commenced on 31 May 2013. There is a 12 month transition period to meet the requirements of TGO 88, which finishes on 31 May 2014.
Sponsors and manufacturers of human blood, blood components, tissues and cellular therapy products who wish to do so may begin complying with TGO 88 before 31 May 2014, but must also ensure that the revised cGMP is or has been observed in the manufacture of their goods, as these are intended to be applied together.
Human blood and blood components, human tissue and human cellular therapy products both collected and released for supply prior to 31 May 2014 (or the time of elected compliance with TGO 88 and cGMP) are exempt from this order.
Section 5 Interpretation
This section provides definitions of the terms that are used within TGO 88. The definitions provided within TGO 88 are specific to the Order and are not intended to apply outside of TGO 88.
Where possible, definitions are derived from current TGA legislation, international regulatory documents or current industry guidance documents. Where a suitable definition has not been identified by those means, the TGA has developed a definition that is informed by equivalent terms used in the aforementioned documents.
Some definitions, such as the definition of 'microbial', have been informed by the Therapeutic Goods Committee Subcommittee on Biologicals (TGC subcommittee) or in the case of 'specified microorganism', informed through public consultation.
The definitions form a part of a glossary that is located in Appendix 14 of the Australian Regulatory Guideline for Biologicals (ARGB). Further clarification on a subset of these definitions is provided below:
- Allogeneic use: this definition intends to capture all non-self transplantation or transfusion, and includes syngeniec use (i.e. between identical twins).
- Asystole: this definition includes cross-clamp time, which for organ donors refers to the time that the aorta is cross clamped by a surgical team. The time of certification of circulatory death would also be considered appropriate if the tissue donor is also a solid organ donor.
- Cornea only donor: this definition recognises that products collected for corneal transplantation may include the cornea as well as surrounding ocular tissue; however, the cornea will be isolated as part of the operative procedure prior to transplantation. The testing requirements for cornea differ to those for other ocular tissue.
- Critical material: the cell or tissue product itself is not included in the definition of critical material. This is the term used for supplies or reagents that come in direct contact with the cell or tissue during any stage of manufacture, such as primary containers or collection kits. Equipment that is used in the manufacturing process such as centrifuges is not a critical material. Compliance with the requirements for substances used in collection and manufacture, including critical materials, must be demonstrated in the relevant section of the product dossier.
- Risk of prion disease: this definition is consistent with the recommendation from the Australian Health Ministers' Conference in 2003 and is consistent with the deferral criteria applicable for blood donors. Further information on assessing the risk of prion disease can be found on the TGA website. Further considerations for the risk assessment may be informed by the World Health Organisation (WHO) categorisation of risk tissue types, European Union (EU) guidelines, European Medicines Agency (EMA) guidance and Food and Drug Administration (FDA) guidelines. 'Iatrogenic' refers to potential exposure through the consumption of, or treatment with, potentially contaminated product e.g. beef products, bovine insulin, blood transfusion or tissue transplantation.
- Specified microorganisms: where products are derived from starting materials have an inherent level of microorganisms, such as skin, the sponsor should develop a list of specified microorganisms of clinical significance, which, if isolated, require rejection of the product for clinical use. This process should be based on a risk assessment and consider the category of tissue, the method of processing and the nature and type of microorganisms that might be present. The definition does not mandate a requirement to test for rickettsia or mycoplasma, but these may be considered significant organisms for particular starting materials.
- Quarantine: products and samples must be segregated from the mainstream inventory until the product has been determined to be compliant with all necessary requirements or release criteria, e.g. where infectious disease test results may not be complete. This is especially relevant for products stored in an inventory (or banked) with other products for potentially long periods of time as these products pose a risk of transmission to other products through physical contact, and a risk to the public from unintentional release and use. Quarantine procedures are assessable under the cGMP. Quarantine practices should be determined based on risk; however, the conditions of quarantine should be consistent with storage conditions wherever possible.
- Physical assessment: examples of the considerations that may inform the physical assessment are provided in Section 11, but additional considerations should be determined on the basis of the product type and intended use.