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Ensuring Good Clinical Laboratory Practice (GCLP) compliance during the
conduct of HIV-1 Vaccine clinical trials at Kenya AIDS Vaccine Initiative (KAVI).
Jackton Indangasi
Kenya AIDS Vaccine Initiative
University of Nairobi
Introduction
KAVI 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.
Implementation process
Key ElementsOrganisation and PersonnelFacilitiesEquipment, materials and reagentsStandard Operating Procedures (SOPs)Planning, conduct and reportingQuality Control and Quality auditsRetention of study records and reports.
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Key Elements: Organization and Personnel
Personnel
laboratory’s greatest asset
Employed qualified professionals
Training of lab staff in GCLP and GCP.
orientation Job description competency assessment professional development continuing education
Key Elements: Organization and PersonnelOrganizational 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 officer
allocated sufficient resources.
Key Elements: FacilityDEMONSTRABLY FIT FOR PURPOSE
SIZE AND SPACEsuitable size, structure and locationspace to avoid sample mix-up or contamination
separation of activitiesRestricted access?storage areas
temperature controlled, monitored, limits set, alarmed, back up
good housekeeping
Facilities, Equipment & Reagents
Equipment acceptance testing prior to use appropriately maintained & calibrated
with records to demonstrate this trend analysis of calibration checks?validated computer systems in usemay need to keep records of usage
Reagents
• suitably labelled and stored
Standard Operating Procedures
Approved by Management
Controlled historical file maintained.
To cover areas such as:
Format, control and review of SOPs
Sample handling- receipt, chain of custody, storage, repeat analysis, etc
Methods or control of methods
Equipment use and maintenance
Record keeping
• QC procedures & Audit procedures
Quality Audits
The 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..
Quality Audits Following the audits a report is issued detailing the findings and
recommendations. Classification of Findings
Critical 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.
Audit Findings from 2005-2012
Results: The laboratory was granted conditional GCLP accreditation on 3rd
February 2006. full accreditation was granted every year from November 2006 up to
2012.
Conclusion
Accreditation 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.