Good Clinical Laboratory Practice (GCLP)

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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 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
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Why not GLP?

• Good standard for work at the bench
• However some conflicts in organisation, roles
  responsibilities and the reporting of results.

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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.

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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

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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.

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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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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

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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 Standard
  Operating 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 work
  performed
• 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 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

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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 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.

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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 methods
• Equipment use and maintenance
• Record keeping
• QC procedures Audit procedures

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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

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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

• 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

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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 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

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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