Good Clinical Laboratory

Practice (GCLP)
Introduction

Dr Stéphania Koblavi-Deme
ICAP Regional Laboratory Advisor
June 21st, 2010
Kigali
 GCLP
• GCLP standards based on GCP and GLP /
Make the link between research and clinical
• 1st published by the British Association of
Research Quality Assurance (BARQA), 2003
• Document standard: ISBN 1-904610-00-5
• Merging guidance from different regulatory
authorities, institutions, international
organizations and accreditation bodies
 What is GCLP?
• GCLP is a quality system for laboratories that
analyze samples for Clinical Trials in accordance
with GCP regulations
• GCLP embraces both research and clinical
aspects of GLP
• GCLP standards correspond to a unified
document to guide the conduct of laboratory
testing for human clinical trial
 GCLP
• GCLP principles help scientist obtain
results which are:
– Reliable (documented, standardized)
– Repeatable (any time in the future)
– Auditable (traceability, audited by third part)
– Recognized by scientists worldwide
• GCLP help in organizational requirement /
not to assess the scientific value of the
study
 GCLP

• Types of lab performing routine, specific

tests
• Labs involved in sample collection,
transportation, analysis or reporting results
for clinical trial such as:
– Hospital
– Company
– Investigator sites
GCLP standards
1. Organization and personnel
2. Laboratory Equipment
3. Test facility operation
4. Quality control plan
5. Verification of performance specification
6. Record and reports
7. Physical facilities
8. Specimen transportation
9. Personnel safety
10. LIS (laboratory information system)
11. Quality management
1 - Standards for organization and
personnel (1)
• Required activities and documentation
– Organizational chart (describe reporting and
communication relationships between staff, lab and
satellite units)
– Personnel policies ( address topic such as orientation for
new staff, continuing education, performance evaluation,
benefits, discipline, holidays, etc.)
– Job description (define qualification, duties for all lab
positions)
– Personnel files (describe job performance: employee
qualification, level of education, training, competency
assessments)
Standards for organization and
personnel (2)
• Job specific training, education, and
assessments
– Job specific training for the clinical trial purpose
(define continuing education requirement)
– Competency assessment (2 x year)
– Job description (specific duties link to the trial)
– Personnel file (include annual evaluation)
– Lab staff signature, codes (identifiers in a signature
log)
2 - Standards for Laboratory Equipment
Equipment = paramount to provide accurate and
reliable results
• Maintenance (support documents are mandatory)
– Curative / repairs (vendors)
– Preventive (lab, daily, weekly, monthly)
– Maintenance plan scheduled or / not need to be
recorded
• Tolerance limits for equipment (T°, humidity, %
CO2, liquid nitrogen level) / Recorded all
information
3 - Standards for test facility operation
Ensure consistency, quality, and integrity of generated
data
• SOPs (Standard Operating Procedures)
– Drafted for all lab activities (format standard)
– SOPs available, accessible
– Documentation should indicated that staff has read and
that SOPs are knowledgeable
• Document control plan
– Establish master list of SOPs
– Periodical reviewing (update SOPs, withdraw obsolete
versions etc.)
4 - Quality control plan (1)
QC program define procedures for monitoring analytic
performance and consistent identification,
documentation and resolution of QC issues
• Tests standards and controls
– Establish individual assay control to ensure assay performance
over time
• Reagents
– Define control limits (quantitative tests)
– Use pos and neg control (qualitative tests, e.g. gram staining,
rapid test)
– QC samples must be performed as patient samples
Quality control plan (2)
• Test specimens
– QCP Establish acceptance / rejection criteria for test
specimen (avoid analytical problems)
– Follow QCP to report specimen results after ensuring
data integrity, quality, accuracy(following the QC plan)
– QCP give recommendations on how to record any
changes on type of analysis
– QCP explain how QC material and reagents must be
prepared, labeled and stored
– QCP Supply of reagents and material (no stock out)
– QCP describe parallel testing for new lot
Quality control plan (3)
• Review of Quality Control Data before test
results are reported
– Lab QCP give guidance to review QC data after
• Changes of analytical reagents
• Major preventive maintenance of equipment services
• Equipment renewal etc.
• Quality control logs
– Help to detect shifts or trends in control data
– Data need to be recorded or plotted in real time
– Information needed (lot number, opening date etc.)
Quality control plan (4)
• QCP give guidance for labeling of QC materials and
reagents
– Prepare and store as requested by the manufacturer
– Properly labeled (expiration date if reagents are
reconstituted)
• QCP how to manage inventory control system
– Avoid stock out
• QCP describe reason and procedures for parallel
testing
– For new batch of lot (test same sample on the current and
new lot)
• Water quality testing
5 - Standards for verification of
performance specification
Give guidance on how to validate an assay
• Required activities and documentation
– Manufactured test need to be validated
– Define the normal range, Analytical Measurement
Range (AMR) and Clinical reportable Range (CRR)
• Verification of performance standards
– Ensure the assay is performing optimally within the
proposed testing environment (define the correct
sample size for evaluation of normal reference
ranges)
• Correction factors
– As needed based on validation exercises
6 - Standards for record and reports (1)
Define and maintain a system to provide and retain
all clinical trial data (manage potential problems
or to reconstruct the study for auditing purposes)

• The system will specify the lab results circuit

from the lab data entry point to the final report,
to the authorized person and or to the test
requestor
 Standards for record and reports (2)
• Type of documents: specimen tracking forms, lab
requisition, chain of custody documents, lab reports,
equipment service and maintenance records,
instruments printed out.
• Required activities and documentation
– Establish a list of test assays employed by the lab
– Define alert or critical values
– Complete procedures in place for immediate notification when
assay results fall within establish alert or critical ranges
– Establish Turn around time for patient results
Standards for record and reports (3)
• Report format
– Standardized report generated by LIS or other
means / concise, readable, and chronological
– Include:
• Patient ID (name, code etc),
• Address of the lab, name of the test,
• Time of sample arrival,
• Specimen source (blood, urine, etc.),
• Specimen criteria for assay acceptability (T, transport system)
• Assay report date
• Assay result
• Unit of measurement / interpretation / ref ranges
Standards for record and reports (4)
• Results modification log and errors in the test
results
– Notify errors ASAP to the clinician / take corrective
action
– Log for results / modifications and corrective action
need to be kept et signed by the lab director
• Archiving reports or records
– Safely and securely manner
– Keep the data reports and records depending on
requirement (national guidelines)
7 - Standards for physical facilities
Environment address safety of the staff, quality of
the pre-analytical, analytical and post analytical
operations
• Required activities and documentation
– Define equipment placement, proper ventilation,
reagent storage condition, data archive with fire
protection, etc.
• General space
– Working area, temperature, humidity for equipment
– Walls, floors, ceilings, bench well maintain
8 - Standards for specimen
transportation
Accuracy of test results depends on the quality
(identity and integrity) of the specimen
• SOPs for collection, transportation and
reception of specimen
• Request form (liaison from site to central lab)
– Time of sampling, phlebotomist ID, patient
demographic info etc.

• Establish shipping procedure

9 - Standards for personnel safety
Safety of all lab staff is paramount to avoid lab
accident
• Required activities and documentation
– Safety policies: universal precaution policy, chemical
hygiene / Hazard communication plan, waste
management policy / Safety equipment
• Equipment and material safety data sheets
– Eye wash, emergency shower, fire extinguisher, PPE,
– Safety training plan
– Safety incident reporting procedures
10 - Standards for LIS (laboratory
information system)
Tool to mange complex processes with
comprehensive reporting and networking
capabilities
• Allow to consolidate data, to improve
reporting, surveillance and networking
capabilities
• Need to establish SOPs for the operation
of the LIS
11- Standards for Quality management

QM program is plan to achieve the lab

quality objectives
• Need to include
– EQA (to externally evaluate lab analytical
performances),
– Required activities documentation
• QM program lead by a the Quality Assurance Audit
including procedures for internal audits, testing
turnaround time (results feed back) and laboratory
communication plan etc.
Documentation / GCLP
 Documentation / GLP

• Handbook: Good Laboratory Practice

(GLP), Quality practices for regulated non-
clinical research and development,
UNDP/World Bank/WHO, special
programme for Reasearch and Training in
Tropical Diseases (TDR)
• http://www.who.int/tdr/publications/publicat
ions/glp-handbook.htm