Presentation on theme: "Kenya AIDS Vaccine Initiative"— Presentation transcript:
1Kenya AIDS Vaccine Initiative Ensuring Good Clinical Laboratory Practice (GCLP) compliance during the conduct of HIV-1 Vaccine clinical trials at Kenya AIDS Vaccine Initiative (KAVI).Jackton IndangasiKenya AIDS Vaccine InitiativeUniversity of Nairobi1
2IntroductionKAVI is currently conducting a Phase I HIV-1 vaccine trial.The implementation of GCLP and pursuit of accreditation in clinical trial laboratories is essential.Best practices and quality assurance issues have become of paramount importance in all clinical trials.
3Implementation process Key ElementsOrganisation and PersonnelFacilitiesEquipment, materials and reagentsStandard Operating Procedures (SOPs)Planning, conduct and reportingQuality Control and Quality auditsRetention of study records and reports.
4Key Elements: Organization and Personnel laboratory’s greatest assetEmployed qualified professionalsTraining of lab staff in GCLP and GCP.orientationJob descriptioncompetency assessmentprofessional developmentcontinuing education
5Key Elements: Organization and Personnel Organizational Structureestablished a working structure that ensures sufficiency at all parts in the laboratory work flow.designated roles and responsibilities; developed an organization chart.designated a Quality Manager and Safety officerallocated sufficient resources.
6Key Elements: Facility DEMONSTRABLY FIT FOR PURPOSESIZE AND SPACEsuitable size, structure and locationspace to avoid sample mix-up or contaminationseparation of activitiesRestricted access?storage areastemperature controlled, monitored, limits set, alarmed, back upgood housekeeping
7Facilities, Equipment & Reagents acceptance testing prior to useappropriately maintained & calibratedwith records to demonstrate thistrend analysis of calibration checks?validated computer systems in usemay need to keep records of usageReagentssuitably labelled and stored
8Standard Operating Procedures Approved by ManagementControlled historical file maintained.To cover areas such as:Format, control and review of SOPsSample handling- receipt, chain of custody, storage, repeat analysis, etcMethods or control of methodsEquipment use and maintenanceRecord keepingQC procedures & Audit procedures
9Quality AuditsThe quality audit system includes a comprehensive program ensuring compliance to GCLP.an annual external audit , in pursuit of accreditation, by Qualogy, UK, an independent accrediting body associated with BARQA (British Association of Research Quality Assurance);Bi-annual audits of safety labs and GCLP compliance by the Clinical Support Laboratory (CLS) South Africa.Monthly internal audits by site staff..
10Quality Audits Classification of Findings Following the audits a report is issued detailing the findings and recommendations.Classification of FindingsCritical non-compliance: Non-compliance affecting the validity of the work conducted at the Laboratory. Accreditation is unlikely to be granted.Major non-compliance: Not affecting the validity of the work but it is a failure to meet the requirements of GCLP standards. Conditional accreditation may be granted.Minor non-complaince: Individual specific observations or recommendations which on their own do not impact on the compliance of the work.
12Results:The laboratory was granted conditional GCLP accreditation on 3rd February 2006.full accreditation was granted every year from November 2006 up to
13ConclusionAccreditation constitutes formal recognition of the laboratory's competence.The implementation of GCLP standards in a laboratory is a slow process but has innumerable advantages.Improved quality systems, results, greater efficiency and teamwork are the key benefits.