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Table 1 Quality assurance requirements

From: Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine

  Requirement
Personnel Appropriate qualification, experience, training and competency
Facilities Upgraded or newly built, suitable capacity, secured, restricted access, adequate cleanliness and protection from contamination
Equipment Appropriate design and capacity, calibrated, validated and adequately maintained
Reagents and specimens Adequate labelling and storage
Process performance Adequate study planning, validation of methods, good documentation practice, QC (daily and EQA surveys)
Documentation Full traceability of activities
SOPs Written and authorized for all activities
Archives Restricted access, secured and documented
Audits Internal audits External independent audits
  1. QC: Quality Control; EQA: External Quality Assessment; SOP: Standard Operating Procedure