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GoodLaboratoryPractise - Coggle Diagram
GoodLaboratoryPractise
Quality Control System that covers managerial process and conditions under which
GLP Principles
Organisation and Personnel
Ensure there are the
relevant facilities, materials, equipment and procedures in place during the study
Staff are
trained
for the relevant study conducted and are responsible for
quality oif study data
Quality Assurance
Appointed by Management and
independent from the study
conducted
Ensures the GLP procedures
are complied with through inspections
Facilities
Ensure degree of
separation
for different activities
Apparatus, Materials and Reagents
Apparatus should be periodically
inspected, cleaned and maintained
Chemicals, solutions and reagents should be
clearly labelled
and fit for purpose
Test system
biological, chemical or physical system used to conduct the study
biological test system
should be maintained well to ensure quality of data. Using animals have strict requirements, since their welfare is priority
Test and reference items
Test items: Identity, composition, concentration, purity etc. should be known
Reference items: Items used for
comparative purposes
SOP
procedures to be followed during the study
Performance of study
Study plan MUST be
authorized and available to staff
BEFORE the study can begin
Raw data must be recorded promptly and accurately
Reporting of study results
there must be a final report containing methods used, results. it must be audited by QA and formally signed. It should declare compliance with GLP. Aborted studies should also be described.
Storage and retention of records and materials
Data transferred to
archive
and can be stored there for many years
Purpose of GLP
Promote
quality and validity
of test data
Reduce need for duplicate testing
of product, shortening time-to-market
promotes mutual recognition of study data
across international frontiers
non-clinical health
and
environmental safety studies
are planned, performed, monitored, recorded, reported and archived
5s for housekeeping
Seiri(Sort)
Sort and remove unnecessary items
Separate unneeded items from needed items and remove unneeded and excess items from workplace,
use
tags
to identify unneeded items and
store most needed items
at common spaces
Seiton(Set in order)
Ensure there is a place for everything and everything is in place
Orderliness, organising,
store
similar items tgt,
dont stack
items
use rack and shelves
, use
human consideration factors like colour, size
and order for quick identification,
label
item and storage area, use storage space
along wall
Seiso(Shine)
Cleanliness and inspection at the same time, staff
trained to clean and maintain their own equipment
and work area
, ensure things are
*
return to neatly new status
so any non-conformity stands out,
inspect and repair tools for wear and tear
that could cause failure during use*
Seiketsu(Standardise)
Procedure and guidelines
created for neatness, health and hygiene,
maintainence system
created for housekeeping, conduct short
briefings
regularly
Shitsuke(Sustain)
Learning the
virtue
of housekeeping, emphasis on
good conduct and discipline,
create
habit
of following rules in workplace, create habit of self-control and self-motivation
Benefits for employees
More
cooperation
between workers
More clean and organised workplaces
more space created when unneeded things are discarded
Awareness of environmental issues
Less stress
, more cosy
Better
discipline
Less chance of accidents
Easier to locate
materials
Benefits for employers
More
productivity
and efficient use of time
Good usage of
equipment and mateirals
Less wastage
of materials
Reduction of
costs
Boosts workers' morale