Euro GTP Guidance - Euro GTPs

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C.3.PROCESSING........................................................................................................................................................... 131 C.3.1. ACTIVITIES ...................................................................................................................................................... 131 C.3.1.1. Reception ...................................................................................................................................................................131 C.3.1.2. Access to the processing facilities ..............................................................................................................................131 C.3.1.3. Processing ..................................................................................................................................................................131 C.3.1.3.1. General...............................................................................................................................................................131 C.3.1.3.2. Processing methods ...........................................................................................................................................131 C.3.1.3.2.1. Organ culture and cell culture ....................................................................................................................132 C.3.1.3.2.2. Decontamination of tissues and cells .........................................................................................................132 C.3.1.3.2.3. Sterilization/disinfection of tissue..............................................................................................................132 C.3.1.3.2.4. Viral inactivation.........................................................................................................................................132 C.3.1.3.2.5. Prion inactivation........................................................................................................................................132 C.3.1.3.2.6. Other processes..........................................................................................................................................132 C.3.1.3.3. Cross contamination...........................................................................................................................................132 C.3.1.4. Quality control ...........................................................................................................................................................133 C.3.1.4.1. Microbiological control ......................................................................................................................................133 C.3.1.4.2. Other controls ....................................................................................................................................................133 C.3.1.5. Packaging and labelling ..............................................................................................................................................133 C.3.1.6. Storage / preservation ...............................................................................................................................................133 C.3.1.6.1. General...............................................................................................................................................................133 C.3.1.6.2. Methods of preservation and storage................................................................................................................133 C.3.1.6.2.1. Preservation and storage at +37�C.............................................................................................................133 C.3.1.6.2.2. Preservation and storage at +4�C...............................................................................................................133 C.3.1.6.2.3. Cryopreservation ........................................................................................................................................133 C.3.1.6.2.4. Glycerolization............................................................................................................................................134 C.3.1.6.2.5. Freeze drying and dehydration...................................................................................................................134 C.3.1.6.2.6. Other methods of preservation and storage..............................................................................................134 C.3.1.6.3. Storage area .......................................................................................................................................................134 C.3.1.7. Documentation and release.......................................................................................................................................134 C.3.1.7.1. General...............................................................................................................................................................134 C.3.1.7.2. Release ...............................................................................................................................................................135 C.3.1.7.3. Processing file contents......................................................................................................................................135 C.3.1.7.4. Availability for inspection...................................................................................................................................135 C.3.1.7.5. Traceability.........................................................................................................................................................135 SECTION D: SPECIFIC SKIN REQUIREMENTS ............................................................................................................ 136 D.1. DONOR SCREENING............................................................................................................................................... 136 D.1.1. ACTIVITIES...................................................................................................................................................... 136 D.1.1.1.Donor detection..........................................................................................................................................................136 D.1.1.2.Donor consent ............................................................................................................................................................136 D.1.1.3. Donor evaluation .......................................................................................................................................................136 D.1.1.3.1.General ...............................................................................................................................................................136 D.1.1.3.2. Medical evaluation.............................................................................................................................................136 D.1.1.3.2.1.Anamnesis...................................................................................................................................................137 D.1.1.3.2.2.Social evaluation .........................................................................................................................................137 D.1.1.3.2.3. Physical evaluation.....................................................................................................................................137 D.1.1.3.2.4. Exclusion criteria ........................................................................................................................................137 D.1.1.3.2.5. Post Morten Time ......................................................................................................................................138 D.1.1.3.2.6. Laboratory test results ...............................................................................................................................138 D.2. RECOVERY ............................................................................................................................................................. 139 D.2.1. ACTIVITIES...................................................................................................................................................... 139 D.2.1.1. Access to the operating room....................................................................................................................................139 D.2.1.2. Recovery ....................................................................................................................................................................139 D.2.1.2.1. General...............................................................................................................................................................139 vii
D.2.1.2.2. Recovery ............................................................................................................................................................139 D.2.1.2.2.1. Donor identification ...................................................................................................................................139 D.2.1.2.2.2. Gowning .....................................................................................................................................................139 D.2.1.2.2.3. Donor preparation .....................................................................................................................................139 D.2.1.3. Reconstruction of the donor......................................................................................................................................139 D.2.1.4. Quality control ...........................................................................................................................................................140 D.2.1.5. Packaging and labelling..............................................................................................................................................140 D.2.1.5.1. Primary packaging and labelling.........................................................................................................................140 D.2.1.6. Storage and transport after recovery ........................................................................................................................140 D.2.1.6.1.Transport after tissue recovery...........................................................................................................................140 D.2.1.7. Documentation and release for processing ...............................................................................................................140 D.3. PROCESSING.......................................................................................................................................................... 141 D.3.1. ACTIVITIES...................................................................................................................................................... 141 D.3.1.1. Reception...................................................................................................................................................................141 D.3.1.2. Access to the processing facilities..............................................................................................................................141 D.3.1.3. Processing..................................................................................................................................................................141 D.3.1.3.1.General ...............................................................................................................................................................141 D.3.1.3.2. Processing methods ...........................................................................................................................................141 D.3.1.3.2.1. Processing of tissues ..................................................................................................................................141 D.3.1.3.2.2. Decontamination of tissues........................................................................................................................142 D.3.1.3.2.3. Sterilisation of tissues ................................................................................................................................142 D.3.1.3.2.4. Inactivation with regard to prions..............................................................................................................142 D.3.1.4. Quality control ...........................................................................................................................................................142 D.3.1.4.1. Microbiological control ......................................................................................................................................142 D.3.1.4.1.1. General principle........................................................................................................................................142 D.3.1.4.1.2. Microbiological controls.............................................................................................................................142 D.3.1.5. Packaging and labelling..............................................................................................................................................144 D.3.1.5.1. Primary packaging and labelling.........................................................................................................................145 D.3.1.6. Storage/ preservation................................................................................................................................................145 D.3.1.6.1. General...............................................................................................................................................................145 D.3.1.6.2. Methods of preservation and storage................................................................................................................145 D.3.1.6.2.1. Preservation and storage at 37ºC ..............................................................................................................145 D.3.1.6.2.2. Preservation and storage at +4°C...............................................................................................................146 D.3.1.6.2.3. Cryopreservation at between ‐60°C and ‐80°C...........................................................................................146 D.3.1.6.2.4. Cryopreservation in liquid nitrogen ...........................................................................................................146 D.3.1.6.2.5. Glycerolisation with a high glycerol concentration ....................................................................................146 D.3.1.6.2.6. Lyophilisation and dehydration..................................................................................................................146 D.3.1.6.2.7. Decelluralisation.........................................................................................................................................146 D.3.1.6.2.8. Other preservation and storage procedures..............................................................................................146 D.3.1.6.3. Storage area.......................................................................................................................................................147 D.3.1.7. Documentation and release.......................................................................................................................................147 D.3.1.7.1. General...............................................................................................................................................................147 D.3.1.7.2. Processing file contents .....................................................................................................................................147 D.3.1.7.3. Availability for inspection...................................................................................................................................147 D.3.1.7.4. Traceability.........................................................................................................................................................147 SECTION E: SPECIFIC CARDIOVASCULAR REQUIREMENTS........................................................................................ 148 E.1 DONOR SCREENING ................................................................................................................................................ 148 E.1.3. ACTIVITIES ...................................................................................................................................................... 148 E.1.3.1.Donor detection ..........................................................................................................................................................148 E.1.3.2.Donor consent.............................................................................................................................................................148 E.1.3.3. Donor evaluation........................................................................................................................................................148 E.1.3.3.1.General................................................................................................................................................................148 E.1.3.3.2. Medical evaluation .............................................................................................................................................148 viii
Page 1 and 2: Euro GTP Guidance EUROGTP Europea
Page 3 and 4: Table of Contents PURPOSE AND SCOPE
Page 5 and 6: A.5.1.4.1.2. Microbiological contro
Page 7: B.3.1.2. Access to the processing f
Page 11 and 12: F.1.1.2.Donor consent..............
Page 13 and 14: PURPOSE AND SCOPE The European Good
Page 15 and 16: SECTION A: GENERAL REQUIREMENTS A.1
Page 17 and 18: a) Ensure that the tissues / cells
Page 19 and 20: These responsibilities may be perfo
Page 21 and 22: 3. This classification should be gu
Page 23 and 24: A.2.1.3. Materials 1. Procurement m
Page 25 and 26: 8. Drains should be of adequate siz
Page 27 and 28: 11. Storage facilities must be prov
Page 29 and 30: 11. The rules of particle count can
Page 31 and 32: 2. When ‘in operation’ requirem
Page 33 and 34: 4. Maintenance workshops should as
Page 35 and 36: 5. A standardized written procedure
Page 37 and 38: 1. A system to ensure that any dece
Page 39 and 40: organ donation, the corpse does not
Page 41 and 42: Explanation of costs involved and t
Page 43 and 44: c) confirmed that all the informati
Page 45 and 46: 4. The extra medical costs incurred
Page 47 and 48: c. confirmed that all the informati
Page 49 and 50: corticosteroids Provide details on
Page 51 and 52: 3. A written report on the findings
Page 53 and 54: a) Any person who stayed in Britain
Page 55 and 56: 3. For any donation, the collection
Page 57 and 58: not required. Retesting is also not
Page 59 and 60:
2. Where tissues and cells of allog
Page 61 and 62:
l) Proof of consent for donation of
Page 63 and 64:
4. It is recommended that the donor
Page 65 and 66:
A.4.1.2.3.2. Reconstruction of the
Page 67 and 68:
A.4.1.5.1. Primary packaging and la
Page 69 and 70:
according to the safety and preserv
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2. The report must also contain the
Page 73 and 74:
c) results of physical examination,
Page 75 and 76:
2. A written procedure designed to
Page 77 and 78:
A.5.1.4. Quality Control 1. The eva
Page 79 and 80:
5. Labels should be designed to adh
Page 81 and 82:
6. Records must be legible and inde
Page 83 and 84:
3. Traceability must be ensured fro
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6. Each tissue bank should establis
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With the growing global circulation
Page 89 and 90:
13. The transport conditions should
Page 91 and 92:
A.6.4. DOCUMENTATION AND RELEASE A.
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1. Member States shall take all nec
Page 95 and 96:
f) Records are made, manually and/o
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4. Member States shall also ensure
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g) Review of all the critical devia
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3. Where tissue that has been relea
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e) Records are made, manually and/o
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g) Initials of the persons who veri
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2. A representative sample should b
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d) Related documents; e) Stages of
Page 111 and 112:
f) Reference of the procedures invo
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g) Additional testing to be carried
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7. For cleaning and disinfection pr
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6. TEs shall provide copies of agre
Page 119 and 120:
5. The procedure for notifying seri
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2. Seriousness might relate to pote
Page 123 and 124:
B.1.1.3.2.4.Exclusion criteria 1. T
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B.1.1.3.2.4.1.3. Infections Persons
Page 127 and 128:
performing staff. This includes due
Page 129 and 130:
The eye must not be immersed in sol
Page 131 and 132:
The package and the mode of transpo
Page 133 and 134:
Additionally, antimicrobial effects
Page 135 and 136:
B.3.1.4.2.1.2.Slit lamp evaluation
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B.3.1.6.2.1.1. Organ culture of cor
Page 139 and 140:
Donor corneas with an endothelial c
Page 141 and 142:
threatening for the recipient(s) or
Page 143 and 144:
d) Placenta storage until earliest
Page 145 and 146:
The methods for discarding donor ti
Page 147 and 148:
C.3.1.7.2. Release See generic requ
Page 149 and 150:
The use of skin allografts for chil
Page 151 and 152:
D.2. RECOVERY D.2.1. ACTIVITIES D.2
Page 153 and 154:
D.3. PROCESSING D.3.1. ACTIVITIES D
Page 155 and 156:
2. With the bacteriological and myc
Page 157 and 158:
D.3.1.5.1. Primary packaging and la
Page 159 and 160:
a) Vitrification; b) Preservation i
Page 161 and 162:
m) Bacterial or fungal endocarditis
Page 163 and 164:
E.3. PROCESSING E.3.1. ACTIVITIES E
Page 165 and 166:
GRADE 3 Normal valve leaflet; Posit
Page 167 and 168:
Petechiae in otherwise perfect graf
Page 169 and 170:
Damaged during dissection in the Ba
Page 171 and 172:
E.3.1.4.1. Microbiological control
Page 173 and 174:
cryopreservation the frozen tissues
Page 175 and 176:
F.1.3.3.2.4. Exclusion criteria 1.
Page 177 and 178:
F.2.1.1.2.2. Gowning Staff performi
Page 179 and 180:
F.2.1.2.3.1.1 Femoral head donors P
Page 181 and 182:
environmental temperatures, a tempe
Page 183 and 184:
ethanol) to remove the chloroform e
Page 185 and 186:
It is also necessary to mention the
Page 187 and 188:
F.3.1.6.2.1. Preservation and stora
Page 189 and 190:
j) Integrity of packaging material.
Page 191 and 192:
CROSS CONTAMINATION: Contamination
Page 193 and 194:
communicable disease, to death or l
Page 195 and 196:
G.2. ACRONYMS ATMP Advance Therapy
Page 197 and 198:
7. Recommendation (98) 2 on provisi
Page 199 and 200:
G.4. TISSUE ESTABLISHMENT DOSSIER 1
Page 201 and 202:
EUSTITE Deliverable 18 Inspection G
Page 203 and 204:
How have the processing methods app
Page 205 and 206:
Section D - Facilities EUSTITE Deli
Page 207 and 208:
Section I - Quality System Please g
Page 209 and 210:
GUIDE FOR AUDITING TISSUE ESTABLISH
Page 211 and 212:
verification. Yes No N/A � Physio
Page 213 and 214:
A.5. TRACEABILITY Is there an effec
Page 215 and 216:
3. Risk assessments carried out for
Page 217 and 218:
Is the label resistant to water? Ye
Page 219 and 220:
Auditor Comments: A.9 RECORDS AND R
Page 221 and 222:
2. Donor identity Is donor identifi
Page 223 and 224:
6. Physical Examination Requirement
Page 225 and 226:
Are serological tests performed on
Page 227 and 228:
Auditor Comments: C.2 RETRIEVAL CON
Page 229 and 230:
Yes No N/A Does the facility mainta
Page 231 and 232:
PART D: TISSUE PROCESSING D.1 GENER
Page 233 and 234:
effectiveness against the desired o
Page 235 and 236:
D.2 EQUIPMENT SUITABILITY, STERILIT
Page 237 and 238:
Is there evidence staff is regularl
Page 239 and 240:
D.4 TRACEABILITY OF TISSUE THROUGH
Page 241 and 242:
Sampling occurs at time critical po
Page 243 and 244:
Are there: � SOP for release in p
Page 245 and 246:
F.4 ADVERSE EVENT/REACTION MONITORI
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