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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.