Importance of GLP:
Laboratory Practice (GLP) ensures that there is a standard framework of
procedures for the way in which steps such as planning, performing, monitoring,
recording, reporting and archiving of laboratory studies are conducted. This is
done by having an SOP which stands for Standard Operating Procedure. The SOP
ensures that there is minimal person to person and test to test variability
because as many factors as possible are being kept constant so that the
independent variables will be the main determinants of the results. This in
turn leads to more consistency in the quality of products that are made and the
results are more likely to be reliable such that the assessments and analysis
of the data can thus be valid.. Furthermore, it will be easier to record and
document the steps that are involved in the experiments and easier and more
effective comparisons between experiments can be made. With simpler documentation
formats and more standardised archiving, it also allows audit visits to be
carried out more smoothly. The GLP also helps to ensure that the results that
have been obtained through the trials carried out comply with the requirements
that have been state by the regulatory authorities hence preventing penalties from
getting imposed on them. With GLP, information about the trial can also then be
traceable, ensuring full transparency. GLP also promotes international
acceptance of tests. This is because, following the same steps can lead to the
similar results hence showing that the results are reproducible and not just a
one-off occurrence. In short, having GLP ensures that the final products made
are safe, efficacious and are of good quality, hence minimising the potential
for adverse effects to occur had there not been such measures taken.
How GLP can be achieved:
GLP can be achieved by adhering to the following steps.
1. It is
important to routinely test the systems to ensure that all equipment is working
the way they should be working.
should Archive all records and materials to be transparent
a. Maintain our records for at least
b. All analytical reports should be signed
and dated by the analytical project manager to show that he accepts the
responsibility of the data and assures the validity of the results.
3. All equipment,
material and facilities should be in optimal condition. Otherwise,
action should be taken.
should be of proper size, put at appropriate locations and be of suitable
distance apart from other facilities so as to not cause any disturbance to each
should be tested out before usage to ensure that there are no problems with it
and the instruments should also be calibrated to prevent systematic errors.
Details of all
samples should be recorded
should have quality assurance programs.
and testing of materials should be standardised.
All materials (reagents and solutions) should be labelled.
The date of opening should be noted.
They should be stored at room temperature and should not be used after
they have expired.
study plan and performance of the study should be monitored closely, and results
at various stages of the study should be reported
should have proper training and competence in terms of education and/or experience to
carry out the specific procedures required in the experiment and there should
be sufficient number of staff
should be specific protocol for carrying out the activities in the experiment.
This should be written in chronological order and should explain how each
procedure is supposed to work.