Euro GTP Guidance - Euro GTPs

A.7.4.5. Cleaning and Disinfection Validation .........................................................................................................................102
A.7.4.6. Revalidation ...............................................................................................................................................................103
A.7.5. CRITICAL THIRD PARTY AGREEMENTS ........................................................................................................... 103
A.7.6. CONTINUITY PLANS / CESSATION OF BANK ................................................................................................... 105
A.8. BIOVIGILANCE........................................................................................................................................................ 106
A.8.1. SERIOUS ADVERSE EVENTS/REACTIONS ........................................................................................................ 106
A.8.2. NOTIFICATION OF SERIOUS ADVERSE REACTIONS (RECIPIENTS) ................................................................... 107
A.8.3. NOTIFICATION OF SERIOUS ADVERSE REACTIONS (LIVING DONORS) ........................................................... 108
A.8.4. NOTIFICATION OF SERIOUS ADVERSE EVENTS............................................................................................... 108
SECTION B: SPECIFIC OCULAR REQUIREMENTS ....................................................................................................... 110
B.1 DONOR SCREENING ................................................................................................................................................ 110
B.1.1. ACTIVITIES ...................................................................................................................................................... 110
B.1.1.1.Donor detection..........................................................................................................................................................110
B.1.1.2.Donor consent.............................................................................................................................................................110
B.1.1.3. Donor evaluation........................................................................................................................................................110
B.1.1.3.1.General................................................................................................................................................................110
B.1.1.3.2. Medical evaluation.............................................................................................................................................110
B.1.1.3.2.1.Anamnesis ...................................................................................................................................................110
B.1.1.3.2.2.Social evaluation..........................................................................................................................................110
B.1.1.3.2.3. Physical evaluation .....................................................................................................................................110
B.1.1.3.2.4.Exclusion criteria .........................................................................................................................................111
B.1.1.3.2.5. Exclusion criteria for scleral tissue donors .................................................................................................114
B.2. RECOVERY.............................................................................................................................................................. 114
B.2.1. ACTIVITIES ...................................................................................................................................................... 114
B.2.1.1. Access to the operating room or other recovery room..............................................................................................114
B.2.1.2. Recovery.....................................................................................................................................................................114
B.2.1.2.1. General...............................................................................................................................................................114
B.2.1.2.2. Deceased donors................................................................................................................................................114
B.2.1.2.2.1. Donor identification ...................................................................................................................................114
B.2.1.2.2.2. Gowning .....................................................................................................................................................114
B.2.1.2.2.3. Donor preparation......................................................................................................................................115
B.2.1.2.2.4. Whole eye retrieval by enucleation............................................................................................................115
B.2.1.2.2.5. Corneoscleral disc retrieval by in situ excision ...........................................................................................115
B.2.1.2.2.6. Scleral tissue recovery ................................................................................................................................115
B.2.1.3. Processing during recovery ........................................................................................................................................116
B.2.1.4. Quality control ...........................................................................................................................................................116
B.2.1.5. Packaging and labelling ..............................................................................................................................................116
B.2.1.5.1. Primary packaging and labelling.........................................................................................................................116
B.2.1.5.1.1. Packaging for organ culture........................................................................................................................116
B.2.1.5.1.2. Packaging for hypothermic storage............................................................................................................116
B.2.1.5.1.3. Whole eye packaging / Moist Chamber Storage ........................................................................................116
B.2.1.5.1.4. Scleral tissue packaging..............................................................................................................................117
B.2.1.5.2. Packaging for cryopreservation..........................................................................................................................117
B.2.1.6. Storage and transport after recovery.........................................................................................................................117
B.2.1.6.1. Storage after tissue recovery .............................................................................................................................117
B.2.1.6.1.1. Storage temperatures ................................................................................................................................117
B.2.1.6.1.2. Storage time ...............................................................................................................................................117
B.2.1.6.2.Transport after tissue recovery...........................................................................................................................118
B.2.1.7. Documentation and release for processing ...............................................................................................................119
B.3. PROCESSING .......................................................................................................................................................... 119
B.3.1. ACTIVITIES ...................................................................................................................................................... 119
B.3.1.1. Reception ...................................................................................................................................................................119
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