REGULATORY SIGNIFICANCE AND SALIENT FEATURES OFGOOD LABORATORY PRACTICE (GLP)IN TOXICOLOGY

WELCOME

NAIR DHANYA V.DEPARTMENT OF VETERINARY PHARMACOLOGY & TOXICOLOGYID NO-RVD/15-02

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.

GLP Mandator

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Toxicity studiesMutagenicity studiesEnvironmental toxicity studies

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

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 StudyDevelopmental Toxicity Skin sensitization (Local Lymph Node Assay)Skin irritationPhototoxicity Eye Irritation/ Corrosion studies

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