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The Human Tissue (Quality and Safety for Human Application) Regulations 2007
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- UK Statutory Instruments
- 2007 No. 1523
- SCHEDULE 2
- Requirements for holding a...
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Requirements for holding a licence under Schedule 1U.K.
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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