1. Kenya 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 Indangasi
Kenya AIDS Vaccine Initiative
University of Nairobi 1

2. 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.

3. Implementation process
Key Elements
Organisation and Personnel
Facilities
Equipment, materials and reagents
Standard Operating Procedures (SOPs)
Planning, conduct and reporting
Quality Control and Quality audits
Retention of study records and reports.

4. Key Elements: Organization and 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

5. Key Elements: Organization and Personnel
Organizational Structure
established 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.

6. Key Elements: Facility
DEMONSTRABLY FIT FOR PURPOSE
SIZE AND SPACE
suitable size, structure and location
space to avoid sample mix-up or contamination
separation of activities
Restricted access?
storage areas
temperature controlled, monitored, limits set, alarmed, back up
good housekeeping

7. Facilities, Equipment & Reagents
acceptance testing prior to use
appropriately maintained & calibrated
with records to demonstrate this
trend analysis of calibration checks?
validated computer systems in use
may need to keep records of usage
Reagents
suitably labelled and stored

8. 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

9. 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..

10. Quality Audits Classification of Findings
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.

11. Audit Findings from

12. Results:
The laboratory was granted conditional GCLP accreditation on 3rd February 2006.
full accreditation was granted every year from November 2006 up to

13. 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.