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0:00
This presentation is about the principles or the concepts of good laboratory practice.
My name is David Long.
I'm the director of a consulting company called Long and
Associates International Consultancy Limited, or LAIC.
We hope companies in the life science industries to
implement and maintain their quality management systems.
We work mostly within the good practices range of regulations,
and I have personally been involved with good laboratory practice for over 30 years.
0:34
As I said, this presentation is about the GLP principles,
and it aims to provide background information on the basics of GLP.
During the presentation, I will attempt to answer the three following questions.
Firstly, where does GLP fit into the current research and development model?
Secondly, why do we need GLP?
Thirdly, what are the basic concepts of GLP?
1:04
To see how GLP fits into the R&D model,
we first need to look at the model.
I have chosen the R&D model of the pharmaceutical industry
to illustrate the points I wish to make during this presentation.
But remember, GLP also applies to the cosmetics industry,
the chemical industry, the agrochemical industry and so on.
1:30
This is a simplified version of
the research and development model of the pharmaceutical industry.
This illustration came from the USA FDA website a few years ago.
Here, the research part is confined to
the small box called discovery on the left hand side of the diagram.
After a molecule has been selected for further study,
it enters a stage of research and development called preclinical studies.
These may also be called nonclinical studies.
Some of the studies are chemical or analytical,
others are safety studies, mostly involving animals.
If the molecule is successful,
it will go on to the next stage of R&D - clinical trials.
These are studies in man.
These clinical trials are subdivided into three phases: phase one, phase two and phase three.
At the end of these trials,
if the molecule is found to be safe and efficacious,
the sponsor will submit a dossier to the receiving authority.
In this case, the USA FDA, requesting marketing authorisation.
This slide shows a different way of illustrating
