This document provides an overview of Good Laboratory Practice (GLP). GLP is a quality system for ensuring non-clinical health and environmental safety studies are properly planned, performed, monitored, recorded and reported. GLP compliance is mandatory for toxicity studies, mutagenicity studies, and environmental toxicity studies. The document lists OECD guidelines for various study types, including acute toxicity, sub-chronic toxicity, carcinogenicity, and reproductive toxicity studies. GLP is an internationally accepted regulation that aims to prove the non-clinical safety of pharmaceuticals, veterinary drugs, pesticides and feed additives.

1. WELCOME
NAIR DHANYA V.
DEPARTMENT OF VETERINARY
PHARMACOLOGY & TOXICOLOGY
ID NO-RVD/15-02

3. Good Laboratory Practice (GLP) is 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.

5. GLP
Mandatory!
GLP
Mandatory!
Toxicity studies
Mutagenicity studies
Environmental
toxicity studies

13.  Documented procedures which describe how
to perform tests or activities normally not
specified in detail in study plans or test
guidelines.

17. OECD Guidelines 401- 460
Acute toxicity (14-Days)
Sub-Acute Toxicity (28-Day)
Sub-Chronic Toxicity (90-Day)
Chronic Toxicity (180 Days)
Carcinogenicity Studies (24 months)
One-Generation Reproduction Toxicity Study
Two-Generation Reproduction Toxicity Study
Developmental Toxicity
Skin sensitization (Local Lymph Node Assay)
Skin irritation
Phototoxicity
Eye Irritation/ Corrosion studies

18. GLP is an internationally accepted, stringent regulation followed in the process
of determination of safety and assessment of potential hazards in pharmaceuticals,
veterinary drugs, pesticides and feed additives. It carries paramount importance in proving
the non-clinical safety of the product to the health regulatory authorities
in countries where the product requires to be marketed.
NON-CLINICAL
STUDIES
CLINICAL
STUDIES
MANUFACTURING