TRAINEE - World Health Organization

1. INTRODUCTION TO THE OECD
PRINCIPLES OF GLP
INTRODUCTION
Good laboratory practice regulations (GLP) became part of the regulatory landscape in
the latter part of the seventies in response to malpractice in research and development
(R&D) activities of pharmaceutical companies and contract facilities used by them.
The malpractice included some cases of fraud, but by far the most important aspect
of poor practice was the lack of proper management and organization of studies used
to complete regulatory dossiers. The investigations of the US Food and Drug Administration
(FDA) in the toxicology laboratories in the USA demonstrated a lack of organization
and poor management which, it was decided, could only be dealt with by
imposing regulations. These regulations are the GLP regulations. First the US FDA,
then the US Environmental Protection Agency (EPA), instituted GLP regulations, and
eventually many nations of the world followed suit.
In 1981, the OECD also published GLP Principles and these have now dominated
the international scene – so far 30 countries (the member states of the OECD) have
signed agreements that make the OECD GLP Principles binding on them. This effectively
makes the OECD Principles an international text.
The intent of GLP was to regulate the practices of scientists working on the safety
testing of prospective drugs. With the obvious potential impact on consumers and
patients recruited for clinical trials, the safety of drugs became a key issue and GLP was
seen as a means of ensuring that scientists did not invent or manipulate safety data and
a means of ensuring that GLP compliant studies are properly managed and conducted.
Hence GLP became the champion of the consumer, the regulatory safeguard, the guarantee
that the safety data were being honestly reported to the registration or receiving
authorities as the basis of a decision whether or not to allow a new drug onto the
market. GLP was imposed on the industry by regulatory authorities, in the same way
as good manufacturing practice (GMP) had been before, and good clinical practice
(GCP) was to be afterwards.
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