Overview of GxP

Lesson Code: GXP-1200. This e-Lesson is aimed at personnel who require an overview of the background, purpose, and implementation of GxP regulations (GLP, GCP, GMP) that aim to provide assurance of the safety, efficacy, and quality of pharmaceutical products. It also details the consequences of non-compliance with these regulations

  • Category: Pharmaceutical GMP - Basics

Description

After taking this e-Lesson you will be able to:

  • List the three characteristics that all drug products must possess
  • Describe the drug development and approval process
  • Define GxP and why it is necessary
  • Explain GLP, GCP, and GMP in terms of their specific objectives
  • Describe the functions of regulatory agencies such as the FDA and EMA
  • Describe the consequences of non-compliance with GxPs


KEYWORDS:  Clinical Trials, Drug Products, Efficacy, Good Clinical Practices, Good Laboratory Practices, Good Manufacturing Practices, Nonclinical Studies, Quality, Regulatory Agencies, Safety