Samenvatting
Summary Good Laboratory Practice (GLP)
- Instelling
- Universiteit Gent (UGent)
samenvatting van alle lessen glp
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Summary Good Laboratory PracticeH1: 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
2
, 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
3
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