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1 Ensuring Good Clinical Laboratory Practice (GCLP) compliance during the conduct of HIV-1 Vaccine clinical trials at Kenya AIDS Vaccine Initiative (KAVI).

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Presentation on theme: "1 Ensuring Good Clinical Laboratory Practice (GCLP) compliance during the conduct of HIV-1 Vaccine clinical trials at Kenya AIDS Vaccine Initiative (KAVI)."— Presentation transcript:

1 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

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 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

12 Results:  The laboratory was granted conditional GCLP accreditation on 3 rd February  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.


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