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Division 5.1 Different types of inspection may be carried out:

United Kingdom

Original text. Later amendments are not shown.

(a) general system-oriented inspections
  • should be on-site and cover all processes and activities, including: organisational structure, policies, responsibilities, quality management, personnel, documentation, data quality, systems for ensuring data protection and confidentiality, facilities, equipment, contracts, complaints and recalls or audits, information communication (within and across borders) and traceability of tissues and cells;

  • (b) thematic inspections
  • should be on-site and cover one or more specific themes, e.g. quality management systems, preparation process, vigilance systems, or donor testing laboratory conditions;

  • (c) desk based reviews
  • do not take place on-site but at a remote location and may cover all processes and activities or focus on one or more specific themes;

  • (d) reinspections
  • may be indicated as follow-up or reassessment to monitor the corrective actions required during a previous inspection.