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

Table 1 Quality assurance requirements

	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

QC: Quality Control; EQA: External Quality Assessment; SOP: Standard Operating Procedure

ISSN: 1475-2875