Summary Good Laboratory Practice

Summary Good Laboratory Practice
H1: Quality issue
 Cost of non-conformity: repairs, cost of transport, administration, image damage
 EXAMEN: ‘describe what you will do before you start using dry shipper to transport
cord blood units’
 T monitoring device that give alarm when T > 135°C
 Put into another box to limit physical damage
(‘this side up’ & ‘human material’ label
 Ensure that there is no more free liquid N2by e.g. Weighing it
 Test for how long dry shipper can maintain T (may take longer if plane misses
connection,…)
 Dry shipper:
 Liquid nitrogen tank in which N2 is adsorbed in solid material
 !as long as liquid N2 = present: T<135°C when T > -135°C  damage to cells
 Quality
 = the extent to which a product/analytical result/service (=immaterial adapts
product to client) fulfills
 = the expectations of the user/client (who?)
=quality requirements
 Increases when provider has knowledge of expectations of customer & this
knowledge drives his actions
 Increases when provider selects customer for optimal fit

H2: Quality assurance
2.1 How to assure quality?
Personnel, premises, equipment, documentation, processes, supply
Frist 3: qualification, training/maintenance
+CAPA = correction & preventive actions
incidents, non-conformities, complaints, Kaizen
& QC (quality control)
& audits (internal, external)
 Deming circle




1

,  QC
 Doesn’t add anything to system e.g. measuring blanks
 The higher the build-in quality, the less QC needed
 EXAM:
 ‘quality of product can increase by performing more QC tests’
no: you can be more sure that quality is OK but it won’t make
product better
 ‘After overnight incubation, no blood again plates show any growth.
The supplier always delivers on time & never before any issues.
How to build in more quality?’
corrective action: start up new culture plate with same sample &
hope it will grow
preventive action: supplier tests 1/some plates of every batch
before sending it out

2.2 Quality systems
Norms/standards: allow products & services to work together
 Quality standards
 ISO9001: defines how QS should be set up (w/o technical parts, very general)
 NIAZ (gezondheidszorg), JACIE (transplantation)
 Different aspects
 Core activities: processes & flows
 Document control
 Measure, analyze & improve quality
 Most used QS
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,  European foundation for quality management
 Organization has to have 9 areas
 International standard organization = ISO9001
 Applicable to any organization
 Doesn’t force you to highest quality but to have control over the
quality & adjust quality to customer expectation
 ISO17025 for regular lab: includes technical requirements
 ISO15189 for medical lab + medical requirement
 Lean
 Focus on efficiency optimize value for customer  customer is willing
to pay for added value
!everything w/o value = WASTE  transport, waiting time
e.g. creating more parking spots @uz bc patients don’t come to uz to
park their car but to see a doctor
 GLP
 No clinical lab studies = in vivo or in vitro exp in which test articles are
studies prospectively in test systems under lab conditions to
determine safety (toxicity)
 NOT
 Studies using humans
 Clinical studies
 Basis exploratory studies
 Study director: responsible for activity
 Principal investigator: responsible for ‘production’
 Quality assurance unit: quality  is study in accordance with:
 Protocol
 Relevant SOPs
 GLP regulations?
 GCP
 Clinical trials (phase I-III)
 GMP
 Manufacturing: ensures that products are consistently produced &
controlled to quality standards appropriate to their intended use
 Production & quality manager both report to qualified person

H3: Document control
3.1 Document life cycle EXAM




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