This may be completed and submitted as Appendix 1 to the dossier.
| 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
- Suggested dossier location; actual location of information may vary depending on the nature of the product, but must be defined under this heading.
- Only a very brief summary is required, the entire dossier will be evaluated.