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ARGB Appendix 4 - Guidance on TGO 88

Australian Regulatory Guidelines for Biologicals (ARGB)

13 February 2014

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Background

This document provides guidance to Therapeutic Goods Order No. 88: 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 (TGO 88).

These requirements are to be applied in conjunction with the revised Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products, 2013 (cGMP) and replace the current Code of Good Manufacturing Practice for blood and tissues (2000).

Applicable products

TGO 88 is a standard applicable to:

  • human blood and blood components including:
    • red cells
    • white cells
    • platelets and
    • plasma (including plasma for fractionation)
  • human tissues and
  • human cellular therapy products (including haematopoietic progenitor cells)

Additional and alternative requirements

The standard specifies the minimum criteria to minimise the risk of infectious disease transmission through the above mentioned therapeutic goods. Additional or higher requirements can be included at a sponsor's discretion or may also be required by a product-specific order or default standard. Further testing as clinically relevant for specific products or patient populations may also be necessary, for example Cytomegalovirus testing where recipients are children or immunocompromised. This guidance also includes a number of references to 'current Therapeutic Goods Order made under section 10 of the Act'. Where specified, this permits the application of alternative requirements from the TGO for a specific product type, recognising that a 'one size fits all' approach may not be appropriate in some circumstances. It may also be appropriate for a manufacturer to apply more stringent requirements for a specific product, for example by performing additional tests not specified in TGO 88 on the donor or product.

The TGA accepts that alternative approaches may be suitable provided there is appropriate justification. Where alternative approaches are used these must be validated by the manufacturer. This justification and supporting validation information is subject to TGA review and approval. It must be provided in the data supporting the application for product approval or in an application for a variation, post approval.

Terminology

The terminology in TGO 88 and this guidance refers to starting materials (i.e. the collected material) as 'blood, blood components, cells and tissues' as distinct from the finished therapeutic good, which is described as 'product' or 'blood, blood component, tissue or cell therapy product'.

Presentation of dossier information

Annex 1 of this guidance includes a reference table to assist the applicant determine the possible locations for information provided in a dossier submitted in support of an application for a biological. Sponsors of blood component products who need to submit a Technical Master File (TMF) demonstrating compliance to TGO 88 should amend the table to reference the specific sections of their TMF.

Information should be submitted in the indicated sections of the application to demonstrate that the requirement has been met. In addition, the table should include a short statement indicating how the requirement is met. Please note that the TGA will evaluate the entire application, so only a brief statement is required.

Review of TGO 88

TGO 88 will be subject to review on a regular basis, as changes in technology, and best practice, requires. Sponsors and manufacturers are encouraged to discuss with the TGA any changes in standard practice or evolving technologies that may affect, or be affected by, the requirements of TGO 88.

Enquires can be sent to the Biological Sciences Section of the TGA via email to bloodandtissues@tga.gov.au.

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