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The Human Tissue (Quality and Safety for Human Application) Regulations 2007

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13.  Directions shall be given for the purpose of securing compliance with the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.U.K.

Relevant provisions of the third Directive
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

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