Good Clinical Laboratory Practice (GCLP)

1. Good Clinical Laboratory Practice (GCLP) Vanessa Grant LSR

2. What standard applies to the analysis of clinical samples? Good Clinical Practice So why do we need another standard? • What ICH GCP says that relates to the laboratory • ‘Systems with procedures that assure the quality of every aspect of the trial should be implemented’. • Essential Documents: certification or accreditation of laboratories

3. Why not GLP? • Good standard for work at the bench • However some conflicts in organisation, roles & responsibilities and the reporting of results.

4. GLP Study Director • Single point of control -responsibility for the overall conduct of study and final report • Approves the study plan & ensures procedures specified are followed • Ensures data is fully documented and computer systems validated • Signs/dates final report to indicate acceptance of responsibility for validity of data and GLP compliance.

5. GCP Sponsor • Initiates the trial • Ensures compliance with protocol and GCP • Selects Investigator (s) • Monitoring of procedures to verify conduct of trial is in compliance and data verifiable • QA and QC • Provides final report

6. GCLP • Provides a bridge between GCP and GLP • Provides framework to organisations on facilities, systems and proceduresto ensure the reliability, quality and integrity of the work and resultsto satisfy GCP expectations.

7. The scope of GCLP • Principles should be interpreted and applied to any laboratory that analyses samples generated during the conduct of a clinical trial • e.g.blood samples for routine screening, pharmacokinetics, analysis of ECG traces

8. The GCLP Principles • 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.

9. Organisation & Personnel • Facility management • Analytical Project Manager • Analytical staff • Archivist • Quality Audit personnel

10. Facility Management • Ensures that the principles of GCP,GCLP are complied with • Provide sufficient, trained staff • Appropriate & available facilities, equipment & materials • SOPs are approved and in place • Ensure Analytical Plan exists • Quality audit and QC programs are in place

11. Facility Management • Key Appointments • Analytical Project Manager • & if necessary document replacement • Archivist (individual or organisation) • Quality Audit personnel • Retain all records that support the work conducted • Retain responsibility for any work subcontracted

12. Analytical Project Manager • Responsible for the overall conduct of the analytical work • Approve analytical plan & ensure plan is followed • Ensure authorisation for any modification is obtained & documented • Ensure results are accurately recorded • Approve the issue of analytical results • Ensure data are archived

13. Analytical Staff • Maintain awareness of GCP, GCLP which apply to their work • Perform trial requirements in accordance with Trial Protocol, Analytical Plan & Standard Operating Procedures. • Maintain prompt, accurate and complete records • Responsible for the quality of their work & data

14. Quality Audit Staff • Independent monitoring of facility • Performs quality audits • review all aspects of the facility and work performed • Reports findings to Analytical Project Manager and Facility Management

15. Facilities, Equipment & Reagents • DEMONSTRABLY FIT FOR PURPOSE • Facilities • suitable size, structure and location • space to avoid sample mix-up or contamination • separation of activities • limited access? • storage areas • temperature controlled, monitored, limits set, alarmed, back up • good housekeeping

16. 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

17. Standard Operating Procedures • Function of SOPs • To establish standard procedures which will ensure quality and integrity of the data • To communicate these procedures to those who will undertake them and underpin training • To leave a permanent record of the methodology employed.

18. Standard Operating Procedures • Approved by Management • Controlled with 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

19. Planning • Documented and approved plan for the work • May form part of the contractual agreement with the sponsor • Should reflect the requirements of the clinical protocol • Should contain sufficient detail to provide clear instruction to staff • Amendments and deviations documented

20. Conduct • In accordance with the plan • Data and results recorded • promptly, indelibly, legibly, signed & dated • Methods validated • Uniform analytical platforms • Definition of raw (source) data • Documented procedure for repeat analysis

21. Conduct • Samples • procedures for receipt, handling, storage, management designed to prevent mix-ups and maintain integrity • adequately labelled at all times • chain of custody- traceability at all times • from shipment schedule to post analysis • Quality Control • external proficiency schemes • internal in-process checks

22. Reporting • Two types of report • Analytical report • Analytical results • Contain information as required by GCLP, Analytical plan and Sponsor • clinical trial number, identity of the facility and APM, dates, results etc. • QC to ensure accuracy • Approved for issue

23. Storage and Retention of Data • Trial data, Analytical plan & Analytical results/reports • Supporting data or information • Organisation charts • Staff records (training, job descriptions, CVs) • Equipment records( maintenance & calibration) • System validation records • Historical file of SOPs • Quality Audit reports • Stored in appropriate facilities

24. Summary • GCLP is concerned with producing reliable results which can be supported and are reconstructable • To meet the challenge of GCP compliance

25. GCLP • For more information contact: BARQA www.barqa.com