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.
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