OBJECTIVES

By the end of this chapter, the student will be able to:

• Define the core concepts of quality, quality assurance, and quality control.
• Outline the ten fundamental principles of Good Laboratory Practices (GLP) and their significance in ensuring quality in pharmaceutical research and development.
• Describe the role and importance of the European Pharmacopoeia (Ph. Eur.) in setting quality standards for medicines and protecting public health.
• Differentiate between the roles and responsibilities of Quality Control (QC) and Quality Assurance (QA) within the pharmaceutical quality management system.