1. Donation and procurement procedures,,
Consent and donor identification (record of consent, method of identification, donor interview),Annex IV, point 1.1,
Donor evaluation: other than autologous donors (assessment of donor's medical and behavioural information and physical examinations),Annex IV, point 1.2,
Procurement procedures for tissue and cells (requirements relating to procurement procedures and instruments),Annex IV, point 1.3,
Donor documentation (record of donor and the procurement),Annex IV, point 1.4,
Packaging (requirements as to packaging and shipping containers),Annex IV, point 1.5,
Labelling of the procured tissue and cells (minimum labelling requirements),Annex IV, point 1.6,
Labelling of the shipping container (minimum labelling requirements),Annex IV, point 1.7,
2. Reception of tissue and cells at the tissue establishment,,
Verification upon arrival (procedures for verification and requirement for quarantine until verification),Annex IV, point 2.1 to 2.3,
Registration of data,Annex IV, point 2.4,

Organisation and management (requirements as to organisational structure, management systems, and third party agreements),Annex I, Part A,
Personnel (number, competence, responsibilities and training),Annex I, Part B,
Equipment and materials (appropriate for use, validation, maintenance, and specifications),Annex I, Part C,
Facilities and premises (suitability, environment, storage, and maintenance),Annex I, Part D,
Documentation and records (standard operating procedures, document control, record reliability),Annex I, Part E,
Quality review (quality management system, investigations, corrective action, and reviews),Annex I, Part F,

Reception of tissue and cells at the tissue establishment,Annex II, Part A,
Processing of tissue and cells (validation, documentation and evaluation of critical procedures),Annex II, Part B,
Storage and release of tissue and cells (criteria to be complied with, including standard operating procedure),Annex II, Part C,
Distribution and recall of tissue and cells (criteria to be complied with, including procedures to be adopted),Annex II, Part D,
Final labelling of tissue and cells containers for distribution (information to be shown on container label or in accompanying documentation),Annex II, Part E,
External labelling of the shipping container (information to be shown on label on shipping container),Annex II, Part F,