Quality Control Laboratory

1
Basic Principles of GMP
Quality Control Laboratory Workshop on GMP and
Quality Assurance of TB products Kuala
Lumpur Malaysia, 21 25 February 2005 Maija
Hietava M.Sci.Pharm Quality Assurance and
Safety Medicines, Medicines Policy and
Standards, Health Technology and Pharmaceuticals
Cluster Tel [phone] Fax
41.22.791.4730 World Health Organization E-mail
hietavam_at_who.int
2
Inspecting the QC laboratory

• Inspection should cover
• Management and Infrastructure
• Materials, equipment and instruments
• Working procedures
• 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

4
Inspecting the QC laboratory

• Inspection should cover (2)
• Materials, equipment and instruments
• Specifications archive
• Reagents
• Reference standards
• Calibration, validation and verification
• Trace-ability

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Inspecting the QC laboratory
Inspection should cover (3) Working
procedures

• Incoming samples
• Analytical worksheet
• Testing
• Evaluation of results
• Retained samples
• OOS situation handling (SOP)

• Sampling
• In-process controls
• Cleaning of the equipment, vessels and containers
• Change control

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• Question no 24
• QC laboratory produces a unique group of
  requirements for every product and material. What
  is this group called.

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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

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Inspecting the QC laboratory

• Performing the Inspection (2)
• Follow the flow verify implementation and
  compliance IN PRACTICE
• 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

10
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
• Trace-ability

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Inspecting the QC laboratory

• Analysis (3)
• Analytical report and trace-ability
• 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

• Question no 25
• Standardized methods of analysis are often found
  in ____________.

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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
• Deep freezers and refrigerators
• Decubators/temperature mapping

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Inspecting the QC laboratory

• Additional points to consider
• Qualification and validation of computers
• Qualification, experience, training of personnel
• See if lab technicians use the current SOP for
  analysis
• Premises, location, space, mix-ups, different
  storage areas
• Out of specifications
• Retained samples
• Utilities and waste
• Environmental control and monitoring

17
Inspecting the QC laboratory

• Other checks
• Water system
• Compressed air
• Steam
• Environmental monitoring
• Waste

18
Inspecting the QC laboratory

• Question no 14
• What materials need to be very well registered,
  stored, labelled, inspected etc.

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• Supplementary Training Modules on Good
  Manufacturing Practice

Inspecting the QC Laboratory