who - training modules -qclabs - part4
TRANSCRIPT
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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
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Inspection should cover (2):
Materials, equipment and instruments
Specifications archive
Reagents
Reference standards
Calibration, validation and verification
Traceability
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Inspection should cover (3):
Working procedures
Incoming samples
Analytical worksheet
Testing
Evaluation of results
Retained samples
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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
Inspecting the QC laboratory