adeagrant.ppt

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