Good Laboratory Practice(GLP) I hope you will understand better. Thank you

1. Good Laboratory
Practice(GLP)

2. Introduction:
Good laboratory practice or GLP is a quality system of management controls for
research laboratories and organizations to ensure the uniformity,
consistency, reliability, reproducibility, quality, and integrity of products in development for
human or animal health (including pharmaceuticals) through non-clinical safety tests; from
physio-chemical properties through acute to chronic toxicity tests.
GLP is an data and operational quality system, is not the same as standards for laboratory
safety - appropriate gloves, glasses and clothing to handle lab materials safely.
GLP is not limited to chemicals and also applies to medical devices, food additives, food
packaging, color additives, animal food additives, other non-pharmaceutical products or
ingredients, biological products, and electronic products.

3. History
GLP was first introduced in New Zealand and Denmark in 1972. GLP was instituted in US
following cases of fraud generated by toxicology labs in data submitted to the FDA (food and drug
admiration) by pharmaceutical companies, Like Industrial BioTest Labs (IBT) was the most
notable case.
These issues were made public in the hearings at the US Congress, which led to the FDA's
publication of Proposed Regulations on GLP in 1976, with establishment of the Final Rule in June
1979.
The Environmental Protection Agency (EPA) had also encountered similar problems in data
submitted to it, and issued its own draft GLP regulations in 1979 and 1980, publishing the Final
Rules in two separate parts in 1983.

4. Why was GLP Created?
In the early 70s FAD become aware of cases of poor laboratory practice all over
the united state. FAD decide to do an in-depth investigation on 40 toxicology labs.
They discover a lots of fraudulent activates and poor lab practices.
Examples of some to these poor lab practices found were
Inadequate test system
Incorrect or inaccurate accounts of the actual lab study
Equipment not been calibrated to standard form, therefore giving wrong
measurements.

5. Principles of GLP:
The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high
quality and reliable test data related to the safety of industrial chemical substances and
preparations. The principles have been created in the context of harmonizing testing
procedures for the Mutual Acceptance of Data (MAD).
 Organization for Economic Cooperation and Development (OECD)
 The principles of GLP aim to ensure and promote safety, consistency, high quality, and
reliability of chemicals in the process of non-clinical and laboratory testing.

6. Purpose of GLP:
The purpose of the Principles of GLP is:
to promote the quality of test data;
to avoid duplication of research;
to improve the protection of human health and environment;
to facilitate international acceptance of test data;
to prevent the creation of technical trade barriers.

8. Advantages:
Increased confidence in the reliability and trustworthiness of laboratory data.
Increased production of right first time results.
Increased overall productivity.
Increased laboratory reputation.
Reduced need for re-work
Reduced time spent on non-revenue earning investigations

9. References:
(GOOD LABORATORY PRACTICE (GLP) TRAINER Special Programme for Research & Training in
Tropical Diseases (TDR) Sponsored by U N I C E F / U N D P / W o r l d B a n k / W H O SECOND
EDITION, n.d.)
(Purpose and Principles of GLP | Medicines | Health and Youth Care Inspectorate, n.d.)
(Nahler, 2009)