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

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 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.

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

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.

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

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

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 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.

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.