Jackton Indangasi Kenya AIDS Vaccine Initiative University of Nairobi

1. 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 • 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 • Equipment • 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 • 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 2005-2012

12. Results: • The laboratory was granted conditional GCLP accreditation on 3rd February 2006. • full accreditation was granted every year from November 2006 up to 2012.

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.