Principles of GLP and Compliance Monitoring | 58286

International Journal of Applied Biology and Pharmaceutical Technology


Principles of GLP and Compliance Monitoring

Pradeep Deshmukh

The Principles of Good Laboratory Practice (GLP) are a managerial
quality control system covering the organisational process and
the conditions under which non-clinical health and environmental
studies are planned, performed, monitored, recorded, reported
and retained (or archived). The OECD Principles of GLP are
followed by test facilities carrying out studies to be submitted to
receiving authorities for the purposes of assessing the health and
environmental safety of chemicals and chemical products which
may also be of natural or biological origin and, in some circumstances,
may be living organisms.
The Principles of GLP define the responsibilities of test facility
management, study director, study personnel and quality assurance
personnel that are operating within a GLP system, and
minimum standards concerning the suitability of facilities and
equipment to perform studies, the need for standard operating
procedures, documentation of raw data, study reports, the archiving
of records, etc.
The main intent of GLP is to regulate the practice of Scientists
working on safety testing of prospective drugs. The safety of a
drug is the key issue and GLP is seen as a means of ensuring that
scientists do not invent or manipulate safety data and ensuring
that studies are properly managed and conducted to obtain valid
experimental data. The GLP regulations are set of rules for good
practice and help researchers to perform their work in compliance
with OECD-GLP principles using approved study plan and standard
operating procedures