GLP address all aspects of a laboratory study intended for submission to a regulatory agency and the intent of regulation is to assure quality and integrity of safety data. (GCP) is an international ethical and scientific quality standard for the design, conduct, Performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we addressed the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights. While GCP is an international quality standard that defines standard which governments can transpose into regulations for clinical trials involving human subjects. The manuscripts describe all aspect of GLP and GCP guideline include protection of animal and human rights respectively as a subject in preclinical and clinical trial and provides assurance of safety and efficacy of newly developed compounds.
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