who - training modules -qclabs - part4

7/30/2019 WHO - Training Modules -QCLabs - Part4

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QC | Slide 1 of 16 June 2006

Good Practices for QualityControl Laboratories

Part 4:Inspecting the laboratory

Supplementary Training Modules onGood Manufacturing Practice

WHO Technical Report Series,No. 902, 2002. Annex 3


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Quality Control Laboratories

Objectives

To discuss ways in which a QC laboratory can

be inspected


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Inspecting the QC LaboratoryElements of the module

Introduction

Part 1: Management & infrastructure

Part 2: Materials, equipment, instruments, and other

devices

Part 3: Working procedures

Part 4: Safety


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Inspection should cover (1):

Management and Infrastructure

Organization and management, quality system,

documentation control and records

Data processing equipment

Personnel

Premises

Equipment and instruments

Inspecting the QC Laboratory


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Materials, equipment and instruments

Specifications archive

Reagents

Reference standards

Calibration, validation and verification

Traceability

Inspecting the QC Laboratory


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Working procedures

Incoming samples

Analytical worksheet

Testing

Evaluation of results

Retained samples

Inspecting the QC laboratory


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Different types or ways of performing theinspection

Routine type similar to a GMP inspection

Inspection Along the Material Flow

Sample to Result Product Specific Approach

Special inspection

Follow-up inspection



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Performing the inspection (1)

Where to start:

Overview of the laboratory walk through

Chemical, Instrumentation, Microbiology, Documentation,

Storage areas

Organizational structure, responsibilities and job descriptions

SOPs and other documents



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Performing the Inspection (2)

Follow the flow verify implementation and compliance

Incoming samples

Test request

Registration in a central register and labelling

Allocation of work

Incoming reagents, chemicals and reference materials

Inspection and storage

Central register



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Analysis (1)

Specifications (from archive) compared to the analytical reports

Tests and limits

Edition, version, pharmacopoeia

All tests performed, pharmacopoeia

Reagents used

Equipment and instruments used



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Analysis (2)

Specification (from archive) compared to the analytical reports

Log books including calculations

Print-outs and sheets

Raw data, chromatograms, spectra

Signatures and dates, evaluation of results

Traceability



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Analysis (3)

Analytical report and traceability

Reference materials, reagents and chemicals: SOPs and

records

Equipment: usage logs, entries, qualification (DQ, IQ, OQ,

PQ), calibration and verification, maintenance, components

(e.g. columns), SOPs and records, manuals



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Analysis (4)Reference materials:

Calibration and verification purposes

Analysis: official reference materials, secondary and working

standards preparation and use

Registration, inspection and labelling

Central register

Information file

Inspection at regular intervals



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Analysis (5)

Equipment:

Qualification protocols and reports

Calibration and verification

SOPs and records

Manuals

Training records



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Additional points to consider

Qualification and validation of computers

Qualification, experience, training of personnel

Premises, location, space, mix-ups, different storage areas

Out-of-specification result investigation

Retained samples

Utilities and waste, environmental control and monitoring



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Other checks

Water system

Compressed air

Steam

Environmental monitoring

Waste


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