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8/14/2019 adeagrant.ppt
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Good Clinical Laboratory
Practice (GCLP)
Vanessa Grant
LSR
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What standard applies to the analysis of
clinical samples?Good Clinical PracticeSo why do we need another standard?
What ICH GCP says that relates to thelaboratory
Systems with procedures that assure the quality of
every aspect of the trial should be implemented.Essential Documents:
certification or accreditation of laboratories
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Why not GLP?
Good standard for work at the bench
However some conflicts in organisation,
roles & responsibilities and the reporting ofresults.
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GCLP
Provides a bridge between GCP and GLP
Provides framework to organisations onfacilities, systems and procedures
to ensure the reliability, quality and
integrity of the work and results
to satisfy GCP expectations.
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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
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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.
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Organisation & Personnel
Facility management
Analytical Project Manager
Analytical staff Archivist
Quality Audit personnel
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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
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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
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Analytical Staff
Maintain awareness of GCP, GCLP which apply
to their work
Perform trial requirements in accordance with
Trial Protocol, Analytical Plan & StandardOperating Procedures.
Maintain prompt, accurate and complete records
Responsible for the quality of their work & data
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Quality Audit Staff
Independent monitoring of facility
Performs quality audits
review all aspects of the facility and workperformed
Reports findings to Analytical Project
Manager and Facility Management
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Facilities, Equipment & Reagents
DEMONSTRABLY FIT FOR PURPOSE
Facilities
suitable size, structure and locationspace to avoid sample mix-up or contamination
> separation of activities
limited access?
storage areas
> temperature controlled, monitored, limits set,
alarmed, back up
good housekeeping
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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
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Standard Operating Procedures
Function of SOPs
To establish standardprocedures 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.
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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 methodsEquipment use and maintenance
Record keeping
QC procedures & Audit procedures
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Planning
Documented and approved plan for thework
May form part of the contractual agreement
with the sponsor Should reflect the requirements of the
clinical protocol
Should contain sufficient detail to provideclear instruction to staff
Amendments and deviations documented
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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
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Conduct
Samplesprocedures for receipt, handling, storage,
management designed to prevent mix-ups and
maintain integrityadequately 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
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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
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Storage and Retention of Data
Trial data, Analytical plan & Analyticalresults/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
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Summary
GCLP is concerned with producing reliable
results which can be supported and are
reconstructable
To meet the challenge of GCP compliance
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GCLP
For more information contact:
BARQA www.barqa.com