Euro GTP Guidance - Euro GTPs

Recommendations

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F.3.1.3.2.2. Sterilisation or decontamination of musculoskeletal tissues and cells.......................................................172 F.3.1.4. Quality control............................................................................................................................................................173 F.3.1.4.1. Microbiological control.......................................................................................................................................173 F.3.1.4.1.1. General Principle.........................................................................................................................................173 F.3.1.4.1.2. Methods......................................................................................................................................................173 F.3.1.5. Packaging and labelling ..............................................................................................................................................174 F.3.1.6. Storage/ preservation.................................................................................................................................................174 F.3.1.6.1. General ...............................................................................................................................................................174 F.3.1.6.2. Methods of preservation and storage ................................................................................................................174 F.3.1.6.2.1. Preservation and storage in hypotermic conditions ...................................................................................175 F.3.1.6.3. Storage area........................................................................................................................................................176 F.3.1.7. Documentation and release .......................................................................................................................................176 F.3.1.7.1. General ...............................................................................................................................................................176 F.3.1.7.2. Release ...............................................................................................................................................................176 F.3.1.7.2.1. Release of musculoskeletal tissue grafts ....................................................................................................176 F.3.1.7.3. Processing file contents......................................................................................................................................177 F.3.1.7.4. Availability for inspection ...................................................................................................................................177 F.3.1.7.5. Traceability .........................................................................................................................................................177 SECTION G ............................................................................................................................................................. 178 G.1. GLOSSARY.............................................................................................................................................................. 178 G.2. ACRONYMS............................................................................................................................................................ 183 EUROPEAN GROUP OF BLOOD AND MARROW TRANSPLANTATION .............................................................................................. 183 EUROPEAN QUALITY SYSTEM FOR TISSUE BANKING.................................................................................................................. 183 ORGANIZATION RESPONSIBLE FOR HUMAN APPLICATION ........................................................................................................... 183 PENETRATING KERATOPLASTY .............................................................................................................................................. 183 G.3. REGULATION OF REFERENCE................................................................................................................................. 184 G.3.1. EUROPEAN UNION......................................................................................................................................... 184 G.3.2. COUNCIL OF EUROPE..................................................................................................................................... 184 G.3.3. WORLD HEALTH ORGANIZATION................................................................................................................... 185 G.3.4. REFERENCE STANDARDS................................................................................................................................ 185 G.4. TISSUE ESTABLISHMENT DOSSIER .........................................................................................................................187 G.5. EQSTB CHECKLIST .................................................................................................................................................. 187 xi
PURPOSE AND SCOPE The European Good Tissue Practice (GTP) guidelines and the adjacent training model have been established as an outcome of the EU-funded project - Euro-GTPs - to provide a complete and detailed tissue banking information package for tissue bankers as well as for tissue establishment (TE) inspectors in Europe. These guidelines bring together the current minimum regulatory requirements of the European tissue and cells Directives and go one step further - incorporating useful good manufacturing practice (GMP) principles and utilizing the expertise of tissue bank experts to provide a set of practical recommendations for good practice in European TEs. The GTPs are developed to be a helpful tool for all kinds of TEs in different phases of their development and evolution as well as for competent authorities (CA) when performing TE inspections. The aim of the Euro-GTP project is to promote the application of these practices throughout Europe so as to increase the know-how and the level of performance of tissue banking staff, and to harmonize the techniques used. By harmonization of the practices to what is broadly considered as optimal, European TEs are expected to be able to routinely provide higher quality and safer tissues for transplantation and hence reduce the risk of disease transmission to recipients throughout Europe and increase the clinical effectiveness of transplanted grafts. This will contribute to a higher confidence in the exchange of tissues for transplant throughout Europe. The GTP guidelines encompass procedural recommendations for (i) donor screening and selection for each tissue type, (ii) tissue procurement, processing, preservation and storage, as well as (iii) recommendations on how to validate these processes. The effectiveness of the recommended procedures has been assessed by putting them into practice in a TE with the required environmental conditions. These guidelines have been structured in two main parts: generic good tissue practices (GTPs) and tissue-specific GTPs. The generic section comprises practical instructions on (i) generic processes carried out in TEs, (ii) risk assessment and (iii) validation methods for donor screening and tissue procurement, processing, preservation and storage, as well as basic requirements concerning infrastructure, personnel, documentation management, etc.. The tissue-specific sections comprise practical instructions on donor screening and tissue 1
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 and 8: B.3.1.2. Access to the processing f
Page 9 and 10: D.2.1.2.2. Recovery ...............
Page 11: F.1.1.2.Donor consent..............
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
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c) results of physical examination,
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2. A written procedure designed to
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A.5.1.4. Quality Control 1. The eva
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5. Labels should be designed to adh
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6. Records must be legible and inde
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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.
Page 93 and 94:
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
Page 99 and 100:
g) Review of all the critical devia
Page 101 and 102:
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
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B.1.1.3.2.4.Exclusion criteria 1. T
Page 125 and 126:
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
Page 137 and 138:
B.3.1.6.2.1.1. Organ culture of cor
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Donor corneas with an endothelial c
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threatening for the recipient(s) or
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d) Placenta storage until earliest
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The methods for discarding donor ti
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C.3.1.7.2. Release See generic requ
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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
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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
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j) Integrity of packaging material.
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CROSS CONTAMINATION: Contamination
Page 193 and 194:
communicable disease, to death or l
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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
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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
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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
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effectiveness against the desired o
Page 235 and 236:
D.2 EQUIPMENT SUITABILITY, STERILIT
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Is there evidence staff is regularl
Page 239 and 240:
D.4 TRACEABILITY OF TISSUE THROUGH
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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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Euro GTP Guidance - Euro GTPs

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