Good Laboratory
Practice
Good Laboratory Practice (GLP) is a quality
system that is concerned with the organisational process and the conditions
under which non-clinical health and environmental safety studies conducted. The
test results generated for purposes of assessment and other uses relating to
the protection of man and the environment in accordance with the principles of
GLP in an OECD Member
country shall be accepted in other Member Countries.
In the OECD Principles on Good Laboratory Practice,
ten main points are laid down to define the general
principles to be followed by a GLP test facility:
·
Definition of test facility’s organisational responsibilities
·
An independent
quality assurance program
·
Test facility requirements
·
Apparatus, reagent and material requirements
·
Test system requirements
·
Test and reference requirements
·
Established and documented Standard Operating Procedure
·
Documented study
planning and conduct
·
Requirements on study reporting
·
Requirements for storage of retention of records and materials
In the European Union,
these principles have been incorporated into various Directives.
According to the Act on Chemicals (744/1989), a test
facility conducting safety studies on chemicals, including pharmaceuticals and
veterinary drugs can apply for a GLP inspection. The test facility should send
an application for inspection to the National Product Control Agency for
Welfare and Health (STTV). National Agency for
Medicines inspects the facilities that conduct
non-clinical safety studies of medicines and STTV inspects test facilities,
which perform studies of other chemicals. STTV makes the decision on the GLP
compliance status based on the inspection report. GLP facilities are inspected
on a regular basis. All inspections are subject to a fee.
Contact person:
Jouni Räisänen
Email: name.surname@sttv.fi
Tel: +358-9-3967 2769
1.11.2007