qc | slide 1 of 16 june 2006 good practices for quality control laboratories p art 4: inspecting the...
TRANSCRIPT
QC | Slide 1 of 16 June 2006
Good Practices for Quality Control Laboratories
Part 4 :Inspecting the laboratory
Supplementary Training Modules on Good Manufacturing Practice
WHO Technical Report Series, No. 902, 2002. Annex 3
QC | Slide 2 of 16 June 2006
Quality Control LaboratoriesQuality Control Laboratories
Objectives
To discuss ways in which a QC laboratory can be inspected
QC | Slide 3 of 16 June 2006
Inspecting the QC LaboratoryInspecting 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
QC | Slide 4 of 16 June 2006
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
QC | Slide 5 of 16 June 2006
Inspection should cover (2):
Materials, equipment and instruments
– Specifications archive
– Reagents
– Reference standards
– Calibration, validation and verification
– Traceability
Inspecting the QC Laboratory
QC | Slide 6 of 16 June 2006
Inspection should cover (3):
Working procedures
– Incoming samples
– Analytical worksheet
– Testing
– Evaluation of results
– Retained samples
Inspecting the QC laboratory
QC | Slide 7 of 16 June 2006
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
Inspecting the QC laboratory
QC | Slide 8 of 16 June 2006
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
Inspecting the QC laboratory
QC | Slide 9 of 16 June 2006
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
Inspecting the QC laboratory
QC | Slide 10 of 16 June 2006
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
Inspecting the QC laboratory
QC | Slide 11 of 16 June 2006
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
Inspecting the QC laboratory
QC | Slide 12 of 16 June 2006
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
Inspecting the QC laboratory
QC | Slide 13 of 16 June 2006
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
Inspecting the QC laboratory
QC | Slide 14 of 16 June 2006
Analysis (5)
Equipment:
Qualification protocols and reports
Calibration and verification
SOPs and records
Manuals
Training records
Inspecting the QC laboratory
QC | Slide 15 of 16 June 2006
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
Inspecting the QC laboratory