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ARGB Appendix 4 - Guidance on TGO 88

Australian Regulatory Guidelines for Biologicals (ARGB)

13 February 2014

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Annex 1: Location of requirements in dossier

This may be completed and submitted as Appendix 1 to the dossier.

Table 1 Summary table of TGO 88 requirements and suggested dossier sections in which they can be addressed
Subsection Summary of TGO 88 requirement Relevant dossier section/s[4] Summary of how requirement is met[5] Reference documents
8(1) General requirements 4.1. Biological starting materials    
9(1) Donor medical and social history for living donors 4.1.1. Donor selection    
9(2) Donor medical and social history for deceased donor 4.1.1. Donor selection    
9(3) Evaluation of medical and social history 4.1.3. Donor evaluation and management    
9(4) Donor deferral 4.1.3. Donor evaluation and management    
9(5) Donor deferrals for products for autologous use 4.1.3. Donor evaluation and management    
9(6) Donor deferral exceptions for plasma for fractionation 4.1.3. Donor evaluation and management    
9(7) Donor deferral exceptions for ocular tissue 4.1.3. Donor evaluation and management    
9(8) Reassessment of donor history for stored product

4.1.3. Donor evaluation and management

4.4.1. Release specifications

   
9(9) Vertical transmission of infectious agents 4.1.3. Donor evaluation and management    
9(10) Deferral for live vaccine recipients 4.1.3. Donor evaluation and management    
9(11) Live vaccine deferral exceptions 4.1.3. Donor evaluation and management    
9(12) Donors vaccinated with killed, subunit or inactivated vaccine 4.1.3. Donor evaluation and management    
9(13) Deferral criteria 4.1.3. Donor evaluation and management    
9(14) Donor age

4.1.4. Donor selection

4.1.3. Donor evaluation and management

   
9(15) Validation of donor age limits 4.1.3. Donor evaluation and management    
10(1) Donor blood sampling 4.1.2. Donor blood sampling and testing    
10(2) Donor blood sampling (timing) 4.1.2. Donor blood sampling and testing    
10(3) Deceased donor blood sampling 4.1.2. Donor blood sampling and testing    
10(4) Testing of blood samples .1.2. Donor blood sampling and testing    
10(5) Blood sample testing methodology (plasma dilution) 4.1.2. Donor blood sampling and testing    
10(6) Blood sample testing methodology/kits 4.1.2. Donor blood sampling and testing    
10(7) Blood sample testing methodology/kits 4.1.2. Donor blood sampling and testing    
10(8) Evaluation of blood sample testing

4.1.3. Donor evaluation and management

4.2.4. Critical steps and intermediates

   
10(9) Blood sample collection and archiving 4.1.2. Donor blood sampling and testing    
10(10) Blood sample retesting 4.1.2. Donor blood sampling and testing    
10(11) Blood sample testing records .1.2. Donor blood sampling and testing    
11(1) Donor evaluation 4.1.3. Donor evaluation and management    
11(2) Donor physical assessment 4.1.2. Donor blood sampling and testing    
11(3) Donor testing requirements

4.1.2. Donor blood sampling and testing

4.1.3. Donor evaluation and management

   
11(4) Donor testing requirements

4.1.2. Donor blood sampling and testing

4.1.3. Donor evaluation and management

   
11(5) Donor testing requirement exceptions

4.1.2. Donor blood sampling and testing

4.1.3. Donor evaluation and management

   
11(6) Donor testing requirements for autologous use

4.1.2. Donor blood sampling and testing

4.1.3. Donor evaluation and management

   
12(1) Microbial contamination minimisation strategy

4.2.2. Description of manufacturing process and process controls

4.2.4. Critical steps and intermediates

4.2.5. Validation of the manufacturing process

   
12(2) Collection of tissues from deceased donor 4.1.4. Collection of starting material    
12(3) Transport and storage conditions prior to processing

4.1.4. Collection of starting material

4.7. Transportation

   
12(4) Transport and storage conditions after processing

4.5. Stability & storage

4.7. Transportation

   
12(5) Product release bioburden specifications

4.4.1. Release specifications

4.4.5. Justification of specifications

   
13(1) Critical materials (microbial contamination)

4.1.4. Collection of starting material

4.2.3. Control of material and equipment

   
13(2) Requirements for critical materials

4.1.4. Collection of starting material

4.2.3. Control of material and equipment

   

Footnotes

  1. Suggested dossier location; actual location of information may vary depending on the nature of the product, but must be defined under this heading.
  2. Only a very brief summary is required, the entire dossier will be evaluated.

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