Euro GTP Guidance - Euro GTPs

Recommendations

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A.3.1.6.5.3.1. Allogeneic use donation.................................................................................................................................42 A.3.1.6.5.3.2. Autologous use donation ...............................................................................................................................43 A.3.1.6.6. Autopsy .....................................................................................................................................................................43 A.3.1.7. Donor evaluation; biological ........................................................................................................................................43 A.3.1.7.1. General.................................................................................................................................................................43 A.3.1.7.2. Allogeneic Donation .............................................................................................................................................45 A.3.1.7.2.1. Heart beating donors ...................................................................................................................................45 A.3.1.7.2.2. Non‐heart beating donors (Post‐mortem removal) .....................................................................................46 A.3.1.7.2.3. Living donors ................................................................................................................................................46 A.3.1.7.3. Autologous Donations..........................................................................................................................................47 A.3.1.7.4. Serum Bank ..........................................................................................................................................................47 A.3.1.8. Documentation and release for recovery ....................................................................................................................47 A.3.1.8.1. General.................................................................................................................................................................47 A.3.1.8.2. Release.................................................................................................................................................................48 A.3.1.8.3. Donor Screening File Contents.............................................................................................................................48 A.3.1.9. Availability for inspection.............................................................................................................................................49 A.3.1.10. Traceability.................................................................................................................................................................49 A.4. RECOVERY................................................................................................................................................................ 50 A.4.1. ACTIVITIES........................................................................................................................................................ 50 A.4.1.1. Access to the operating room......................................................................................................................................50 A.4.1.2. Access to an unusual place of recovery .......................................................................................................................51 A.4.1.3. Recovery ......................................................................................................................................................................51 A.4.1.3.1. General.................................................................................................................................................................51 A.4.1.3.2. Deceased donors..................................................................................................................................................52 A.4.1.3.2.1. Recovery procedure of tissues .....................................................................................................................52 A.4.1.2.3.2. Reconstruction of the donor's body.............................................................................................................53 A.4.1.3.3. Living donors ........................................................................................................................................................53 A.4.1.4. Processing during recovery..........................................................................................................................................53 A.4.1.5. Packaging and labelling................................................................................................................................................53 A.4.1.5.1. Primary packaging and labelling operation..........................................................................................................55 A.4.1.5.2. Secondary packaging and labelling operation......................................................................................................55 A.4.1.6. Storage and transport..................................................................................................................................................56 A.4.1.6.1. Storage .................................................................................................................................................................56 A.4.1.6.2. Transport..............................................................................................................................................................56 A.4.1.7. Documentation and release for processing .................................................................................................................57 A.4.1.7.1. General.................................................................................................................................................................57 A.4.1.7.2. Release.................................................................................................................................................................58 A.4.1.7.3. Recovery File Contents.........................................................................................................................................58 A.4.1.7.4. Availability for inspection.....................................................................................................................................59 A.4.1.7.5. Traceability...........................................................................................................................................................59 A.5. PROCESSING ............................................................................................................................................................ 59 A.5.1. ACTIVITIES........................................................................................................................................................ 59 A.5.1.1. Reception.....................................................................................................................................................................59 A.5.1.1.1. Receipt of tissues and cells at processing centre .................................................................................................60 A.5.1.1.2. Verification of tissues received ............................................................................................................................61 A.5.1.1.3. Identification of tissues and cells .........................................................................................................................62 A.5.1.2. Access to the processing facilities................................................................................................................................62 A.5.1.3. Processing ....................................................................................................................................................................63 A.5.1.3.1. General.................................................................................................................................................................63 A.5.1.3.2. Processing methods .............................................................................................................................................64 A.5.1.3.3. Cross contamination ............................................................................................................................................64 A.5.1.4. Quality Control.............................................................................................................................................................65 A.5.1.4.1. Microbiological control ........................................................................................................................................65 A.5.1.4.1.1. General Principle ..........................................................................................................................................65 iii
A.5.1.4.1.2. Microbiological controls...............................................................................................................................65 A.5.1.5. Packaging and labelling................................................................................................................................................65 A.5.1.5.1. Packaging and labelling materials management..................................................................................................66 A.5.1.5.2. Primary packaging and labelling operation..........................................................................................................67 A.5.1.5.3. Secondary packaging and labelling operation......................................................................................................67 A.5.1.6. Documentation and release in distribution .................................................................................................................68 A.5.1.6.1. General.................................................................................................................................................................68 A.5.1.6.2. Release.................................................................................................................................................................69 A.5.1.6.3. Processing File Contents ......................................................................................................................................69 A.5.1.6.4. Availability for inspection.....................................................................................................................................70 A.5.1.6.5. Traceability...........................................................................................................................................................70 A.6. STORAGE AND DISTRIBUTION.................................................................................................................................. 72 A.6.1. GENERAL .......................................................................................................................................................... 72 A.6.2. DISTRIBUTION .................................................................................................................................................. 73 A.6.3. IMPORT AND EXPORT ...................................................................................................................................... 74 A.6.4. DOCUMENTATION AND RELEASE .................................................................................................................... 79 A.6.4.1. General.........................................................................................................................................................................79 A.6.4.2. Release.........................................................................................................................................................................79 A.6.4.3. Storing and Distribution File Contents .........................................................................................................................79 A.6.4.4. Availability for inspection.............................................................................................................................................80 A.6.4.5. Traceability...................................................................................................................................................................80 A.7. QUALITY MANAGEMENT ......................................................................................................................................... 80 A.7.1. QUALITY ASSURANCE....................................................................................................................................... 80 A.7.1.1. General.........................................................................................................................................................................80 A.7.1.2. Documentation ............................................................................................................................................................82 A.7.1.3. Non‐compliance management.....................................................................................................................................84 A.7.1.4. Internal Audit ...............................................................................................................................................................84 A.7.1.5. Product Quality Review/Process Quality Review.........................................................................................................85 A.7.1.5.1. Donor screening...................................................................................................................................................86 A.7.1.5.2. Recovery...............................................................................................................................................................86 A.7.1.5.3. Processing ............................................................................................................................................................87 A.7.1.5.4. Distribution ..........................................................................................................................................................88 A.7.1.6. Recalls ..........................................................................................................................................................................88 A.7.1.7. Complaints and returns................................................................................................................................................89 A.7.2. QUALITY CONTROL........................................................................................................................................... 90 A.7.2.1. General.........................................................................................................................................................................90 A.7.2.2. Documentation ............................................................................................................................................................91 A.7.2.3. Sampling.......................................................................................................................................................................91 A.7.2.4. Testing..........................................................................................................................................................................92 A.7.2.5. Stability Monitoring .....................................................................................................................................................93 A.7.2.6. Expiry Date...................................................................................................................................................................94 A.7.3. QUALITY RISK MANAGEMENT ......................................................................................................................... 95 A.7.4. VALIDATION ..................................................................................................................................................... 95 A.7.4.1. General.........................................................................................................................................................................95 A.7.4.2. Documentation ............................................................................................................................................................96 A.7.4.3. Facility, system and equipment qualification...............................................................................................................97 A.7.4.3.1. Qualification for new facilities, systems and equipment .....................................................................................97 A.7.4.3.2. Qualification of established (in‐use) facilities, systems and equipment ..............................................................99 A.7.4.3.3. Qualification of Clean Rooms...............................................................................................................................99 A.7.4.3.4. Qualification of Laminar Flow Hoods .................................................................................................................100 A.7.4.4. Process validation ......................................................................................................................................................100 A.7.4.4.1. Prospective validation........................................................................................................................................100 A.7.4.4.2. Concurrent validation.........................................................................................................................................101 A.7.4.4.3. Retrospective validation.....................................................................................................................................101 iv
Page 1 and 2: Euro GTP Guidance EUROGTP Europea
Page 3: Table of Contents PURPOSE AND SCOPE
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 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
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2. Where tissues and cells of allog
Page 61 and 62:
l) Proof of consent for donation of
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4. It is recommended that the donor
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A.4.1.2.3.2. Reconstruction of the
Page 67 and 68:
A.4.1.5.1. Primary packaging and la
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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
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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
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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
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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
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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
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B.1.1.3.2.4.1.3. Infections Persons
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performing staff. This includes due
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The eye must not be immersed in sol
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The package and the mode of transpo
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Additionally, antimicrobial effects
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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
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Donor corneas with an endothelial c
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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
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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.
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
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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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