The Clause-based mapping document shows how the requirements in TGO 109 arose from TGOs 83, 84, 85, 86 and 88.
For further information see:
| TGO109 | Sunsetting TGO | Regulatory requirement | Summary of change from current standard |
|---|---|---|---|
| Part 1 - Preliminary | |||
| 4 | TGO 83-87 - 4 | No change | Definitions - Redrafted to clarify intent |
| 6 (1) | Not in standard | Increase | Applications to all Biologicals. TGO83-87 apply only to Class 2 Biologicals |
| 6 (2)(a) | Not in standard | No change | New - Clarification for standard does not apply to FMT products |
| 6 (2)(b) | Not in standard | Decrease | Exemption to 'Exempt Autologous HCT products' |
| 6 (2)(c) | TGO88 - 7(2) | No change | No change |
| Part 2 - Diseases and conditions that may compromise biologicals | |||
| 9 | TGO88 9(13-15) | Increase | Scope increased from infectious disease or age to any condition or disease. |
| Part 2 - Critical materials | |||
| 10(1)(a) | TGO88 - 13(1) | No change | Redrafted to clarify intent |
| 10(1)(b) | TGO83-86 7(1) | Increase | No change - Intent clarified for all biologicals |
| 10(1)(c-e) | 13(2)( a-c) | No change | No change |
| 10(2) | TGO88 13(2)(d) | No change | No change |
| Part 2 - Microbial contamination control strategy | |||
| 11 | TGO 88 12(1) | Decrease | Re-drafted to allow alternatives based on technical advancement |
| Part 2 - Samples for bioburden testing | |||
| 12(1) | TGO88 12(5) | No change | Redrafted to clarify intent |
| 12(2) | TGO88 12(5) | No change | Redrafted to clarify intent |
| 12(3) | Not in standard | No change | New - Clarifies exemptions for ocular tissue |
| Part 2 - Bioburden testing requirements | |||
| 13(1) | TGO83 7(9) & TGO86 7(4) | Increase | Redrafted to clarify intent - now applies to all biologicals |
| 13(2) | TGO83 7(9) & TGO86 7(4) | Increase | Re Redrafted to clarify intent now applies to all biologicals |
| 13(3) | TGO88 12(5)(a-b) | No change | No change |
| 13(4) | Not in standard | No change | New - Clarifies exemptions for ocular & cardiovascular |
| 13(5) | Not in standard | No change | New - Clarifies exemptions for musculoskeletal & cardiovascular |
| Part 2 - Sterilisation | |||
| 14(1) | TGO88 12(5)(e) | No change | No change |
| Part 2 - Collection from deceased donors | |||
| 15(1) | TGO88 12(2) | No change | Redrafted to clarify intent |
| 15(2) | Not in standard | No change | New - Clarifies exemptions for musculoskeletal, ocular and amnion |
| Part 2 - Storage and transportation | |||
| 16(1) | TGO88 12(3) | No change | Redrafted to clarify intent |
| 16(2) | Not in standard | No change | New - Clarifies exemptions for musculoskeletal, ocular and amnion |
| 16(3) | TGO83 7(4), TGO86 7(2) | Increase | Redrafted to clarify intent - now applies to all biologicals |
| 16(4) | TGO88 12(4) | No change | Redrafted to clarify intent |
| 16(5) | Not in standard | No change | New - Clarifies exemptions for musculoskeletal, cardiovascular, ocular, skin and amnion |
| 16(6) | Not in standard | Increase | New - Requirements for re-release of returned biological |
| Part 2 - Containers of biologicals | |||
| 17(1) | TGO83 7(11) TGO84 7(6) TGO86 7(7) |
Increase | No change - Requirement now applies to all biologicals |
| 17(2) | Not in standard | No change | New - Clarifies exemptions for ocular |
| Part 3 - Standard for human musculoskeletal products | |||
| Collection from deceased donors | |||
| 20 | TGO83 7(2) | No change | No change |
| Bioburden testing | |||
| 21 | TGO83 7(5-8) | No change | No change |
| Demineralised products | |||
| 22 | Not in standard | Increase | New - Limits for residual calcium in demineralised products |
| Freeze dried products | |||
| 23 | Not in standard | Increase | New - Specifies residual moisture limits in freeze-dried products |
| Storage and transport | |||
| 24 | TGO83 7(12) | Increase | Clarification that storage is from 'collection' and not 'completion of processing'. |
| 24 (a) (iii) | Not in standard | Increase | New - Specifies storage conditions for freeze-dried products |
| Clauses from Part 2 which apply to musculoskeletal products | |||
| Part 2 - 9, 10,11, 12,13(1), 14, 16(1), 16(4), 16(6) & 17(1) | |||
| Part 4 - Standard for relevant human cardiovascular tissue products | |||
| Tissue not subjected to a bioburden process | |||
| 27 | TGO84 7(2) | No change | No change in requirement. Term 'manufacture' replaced with 'processing' and bioburden sampling point clarified |
| Tissue subjected to a bioburden reduction process | |||
| 28 (1-4) | TGO84 7(3) | No change | Redrafted to clarify intent |
| 28 (5) | Not in standard | Increase | New - Specifies processing completion timeframes |
| Heart valves | |||
| 29 | TGO84 7(5) | No change | No change |
| Storage and transport | |||
| 30(1) | TGO88 12(3) | No change | No change in requirement - Clarification that timeframes for 72 hours in transportation do not apply as processing to be completed or initiated prior to that. Clarification that temperature below 10°C imply 0° -10°C |
| 30(2,3) | TGO84 7(7) | No change | No change in requirement Clarification that storage duration is from 'collection'. |
| Clauses from Part 2 which apply to Cardiovascular products | |||
| Part 2 - 9,10,11,12, 14,15,16 and 17 | |||
| Part 5 - Standard for relevant human ocular tissue products | |||
| Collection | |||
| 33 | TGO85 7(2,3) | Increase | Clarification that collection must be 'completed' and not 'commence' consistent with timeframes and requirements specified in rest of the standard. |
| Storage and transportation | |||
| 34 (a, b and d) | TGO85 7(4) | No change | Clarification that storage duration is from 'collection'. |
| 34 (c) | Not in standard | Increase | New - Specifies storage conditions for sclera |
| Testing of storage medium | |||
| 35 | TGO85 7(5) | No change | No change |
| Containers | |||
| 36 | TGO85 7(6) | No change | No change |
| Examination and evaluation | |||
| 37 | TGO85 8(1) | No change | No change |
| Clauses from Part 2 which apply to ocular products | |||
| Part 2 - 9,10,11,14 and 16(1) | |||
| Part 6 - Standard for relevant human skin products | |||
| Collection | |||
| 40(1) | TGO86 7(2) | No change | No change in requirement - Re-drafted for clarification |
| 40(2) | Not in standard | Increase | New - Specifies time limits when collection must commence |
| Microbial contamination | |||
| 41 | TGO86 7(4,5) | No change | No change |
| Freeze-dried products | |||
| 42 | Not in standard | Increase | New - Specifies residual moisture limits for freeze-dried products |
| Storage and transportation | |||
| 43(1) | TGO88 12(3) | No change | No change in requirement - Clarified that timeframes for 72 hours in transportation do not apply as processing initiates or completes prior to that based on other requirements for such products |
| 43(2) | TGO86 7(8) | No change | No change |
| Clauses from Part 2 which apply to skin products | |||
| Part 2 - 9,10,11,12, 13(1-2), 13(5),14,15,16(2-6) and 17 | |||
| Part 7 - Standard for relevant human amnion products | |||
| Collection | |||
| 46 | Not in standard | Increase | New - Specifies collection times |
| Terminal sterilisation | |||
| 47 | Not in standard | Increase | New - Specifies requirements for amnion collected from vaginal delivery |
| Dehydrated and Freeze-dried products | |||
| 48 | Not in standard | Increase | New - Specifies residual moisture limits |
| Storage and transportation | |||
| 49(1) | Not in standard | Increase | New - Specifies transport conditions for material pre-processing |
| 49(2,3) | Not in standard | Increase | New - Specifies storage conditions for amnion products |
| Clauses from Part 2 which apply to amnion products | |||
| Part 2 - 9, 10, 11, 12,13,14,16(3-6) and 17 | |||