Chapter II: Quality control of drugs in pharmacies
Résumé de section
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This chapter introduces the fundamental principles of quality control for drugs in pharmacies. It begins by defining key concepts like "quality" and "quality assurance" according to international standards. The chapter then explores the critical frameworks that ensure drug safety and efficacy, including Good Laboratory Practices (GLP) for research and the standards of the European Pharmacopoeia for quality control. Finally, it distinguishes between the roles of Quality Control (QC) and Quality Assurance (QA), highlighting their interconnected responsibilities in guaranteeing that every pharmaceutical product is effective, safe, and reproducible.
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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.
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