Good Laboratory Practice pdf
GLP
is a formal regulation created by USFDA as these regulations were proposed on
November 19,1976 and designated as a new part of Chapter 21 of the Code of Federal
Regulations(CFR) as 21 CFR Part 58 in 1979.
In
1981 an organization named OECD (Organization for Economic Cooperation
And
Development) produced GLP principles that
are international standards GLP in OECD principles is defined as “a quality system
concerned with the organizational process and the conditions under which
non-clinical health and environmental safety studies are planned, performed,
monitored, recorded, archived and reported”.
GLPs
were initially invoked in a reaction to malpractices in the
laboratories
conducting safety experiments of medicines.
In
the early 1970s, research laboratories in the USA found doing work in unethical
ways, like:
Data
generation without conduct of the study.
Falsification
of the laboratory work.
Replacement
of dead animals and fabrication of test results etc.
Advantages of GLP
Assures
that the data are a true reflection of results obtained from studies.
Preclinical
safety and residue safety.
Generation
of high quality and reliable test data.
Mutual
acceptance of data
Increases
public confidence.
Shortens
the time-to-market for new products.
View
in PDF File
