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Supplementary Training Modules on Good Manufacturing Practice

Good Practices for Quality Control Laboratories

Part 4:

Inspecting the laboratory


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 Laboratory


Elements 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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Inspecting the QC Laboratory


Inspection should cover (1):
Management and Infrastructure Organization and management, quality system, documentation control and records Data processing equipment Personnel Premises Equipment and instruments

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Inspecting the QC Laboratory


Inspection should cover (2):
Materials, equipment and instruments Specifications archive Reagents Reference standards

Calibration, validation and verification


Traceability

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Inspecting the QC laboratory


Inspection should cover (3):
Working procedures Incoming samples Analytical worksheet Testing

Evaluation of results
Retained samples

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Inspecting the QC laboratory


Different types or ways of performing the inspection
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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Inspecting the QC laboratory


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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Inspecting the QC laboratory


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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Inspecting the QC laboratory


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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Inspecting the QC laboratory


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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Inspecting the QC laboratory


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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Inspecting the QC laboratory


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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Inspecting the QC laboratory


Analysis (5)
Equipment: Qualification protocols and reports Calibration and verification SOPs and records Manuals Training records

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Inspecting the QC laboratory


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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Inspecting the QC laboratory


Other checks
Water system Compressed air Steam Environmental monitoring Waste

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