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Pharmaceutical Quality Assurance

Course Description: This advanced course offers a comprehensive study of the principles and systems that ensure the quality, safety, and efficacy of pharmaceutical products. Students will critically examine Good Manufacturing Practices (GMP), quality assurance, quality control, validation processes, and regulatory frameworks. The course emphasizes the application of these principles through case studies, regulatory documentation, and problem-solving exercises relevant to modern pharmaceutical manufacturing and quality systems.
Credits: 2
Objectives of the course :

This course aims to:
1. Build a comprehensive understanding of modern pharmaceutical quality systems, including the regulatory foundations of good manufacturing practices and the essential roles of quality assurance and quality control.
2. Build competency in executing key quality assurance processes, including validation protocol design, calibration program management, and conducting stability studies to ensure ongoing compliance and product integrity.

Course outputs :

Knowledge and Understanding
1.1 Description of Good Manufacturing Practices (GMP) Regulations and Their Application in Pharmaceutical Systems
1.2 Identification and classification of quality variation sources and their impact on product quality and patient safety.
2. Skills:
2.1 Differentiating between various quality systems (Good Manufacturing Practices, Good Laboratory Practices, and Good Storage Practices) and their applications.
2.2 Development of Quality Control Procedures for Different Dosage Forms.
3. Values, Independence, and Responsibility:
3.1 Demonstrate decision-making ability in various quality aspects.
3.2 Demonstrate integrity, trustworthiness, self-confidence, self-awareness, and entrepreneurial potential in various environments.

Additional information:
  • Last updated: 2026-05-13

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