Description about GLP

1. Good Laboratory
practice
In the experimental (non-clinical) research arena, 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

2.  GLP was first introduced in New
Zealand and Denmark in 1972, and later
in the US in 1978 in response to
the Industrial BioTest Labs scandal. It was
followed a few years later by
the Organization for Economic Co-
operation and Development (OECD)
Principles of GLP in 1992; the OECD has
since helped promulgate GLP to many
countries.

3.  GLP applies to non-clinical studies conducted for the
assessment of the safety or efficacy of products in
development (including pharmaceuticals) for people,
animals, and the environment.[1] GLP, a data and
operational quality system, is not the same as standards
for laboratory safety - appropriate gloves, glasses and
clothing to handle lab materials safely.
 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.
 GLP is not limited to chemicals and also applies to medical
devices, food additives, food packaging, colour additives,
animal food additives, other non-pharmaceutical products
or ingredients, biological products, and electronic products.

4.  GLP principles include

Organization and Personnel
◦ Management-Responsibilities
◦ Sponsor-Responsibilities
◦ Study Director-Responsibilities
◦ Principal Investigator-Responsibilities
◦ Study Personnel-Responsibilities

5.  2.0 Quality assurance program
◦ Quality Assurance Personnel


6.  Facilities
◦ Test System Facilities
◦ Facilities for Test and Reference Items

7.  4.0 Equipment, reagents and materials

8.  5.0 Test systems
◦ Physical/Chemical
◦ Biological

9.  6.0 Test and reference items

10.  7.0 Standard operating procedures

11.  8.0 Performance of study
 Study Plan
 Conduct of Study

12.  9.0 Reporting of results

13.  10.0 Archival - Storage of Records and
Reports

14.  OECD Guidelines for the Testing of
Chemicals[edit]
 OECD publishes OECD Guidelines for the
Testing of Chemicals, which are guidelines
that usually have to be followed for GLP
compliance. They are widely required by
agencies doing risk assessments of
chemicals.

15.  The US FDA
 The United States FDA has rules for GLP in
21CFR58. Preclinical trials on animals in the
United States of America use these rules
prior to clinical research in humans.
 Research in the US not conducted under
these restrictions or research done outside
US not conducted according to the OECD
Guidelines (or FDA rules) might be
inadmissible in support of a New Drug
Application in the US.

16.  European Union
 Since 1987 the European Council had
adopted two basic Directives and a
Decision relating to the application of the
GLP principles. Directive 2004/10/EC has
replaced Directive 87/017/EEC as of 11
March 2004; Directive 2004/9/EC has
replaced Directive 88/320/EEC as of 11
March 2004.

17. Directive 2004/10/EC of the
European Parliament and of the
Council of 11 February 2004 on the
harmonisation of laws, regulations
and administrative provisions relating
to the application of the principles of
good laboratory practice and the
verification of their applications for
tests on chemical substances

18.  Automated systems
 In many instances, the optimal
recommended "no-argument" means of
implementing GLP is to develop an
automated approach to both sample
preparation and sample measurement. GLP
compliance then generally entails including
an overarching "chain of custody" sample
history and data flow, combined with
adequate standard operating procedures for
calibration and linearization of measuring
tools.