PHARMACEUTICAL CHEMISTRY 4

COURSE OUTLINE

Course Description: A course that deals with the application of concepts and tools of quality
management systems in the manufacture of safe and effective pharmaceutical
and cosmetic products. It focuses on the organization and principles of quality
assurance, and quality control of raw materials, intermediate products, bulk
products and finished products, with emphasis on the instrumental methods of
analysis.
Topics:
Unit I Instrumental Methods of Analysis
1. Introduction to Instrumentation
2. Different Methods, Their Uses and Applications
2.1 Spectrometry
2.1.1 UV-Vis Spectroscopy
2.1.2 Infrared Spectrophotometry
2.1.3 Atomic Spectrophotometry
2.1.4 Molecular Emission Spectrophotomtery
2.1.5 Nuclear Magnetic Resonance
2.1.6 Turbidimetry
2.1.7 Nephelometry
2.1.8 X-ray Diffraction
2.2 Chromatography
2.2.1 Gas Chromatography
2.2.2 High Performance Liquid Chromatography
2.3 Electrochemical
2.3.1 Potentiometry
2.3.2 Coulometry
2.3.3 Polarography
2.4 Miscellaneous
2.4.1 Mass Spectrometry
2.4.2 Radioactivity
Unit II
3. In-process control of different dosage forms
3.1 Solid dosage forms
3.2 Liquid dosage forms
3.3 Semi-solid dosage forms
4. Quality Management System
4.1 Quality Management System Quality Control and Quality Assurance
4.2 Standards
4.3 Classification of defects
5. Inspection and Sampling
5.1 Sampling tools and techniques
5.2 Sampling plans
Unit III
6. Control of Sources of Variations in Manufacturing
6.1 Material
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6.2 Manufacturing
6.3 Packaging
6.4 Distribution
6.5 Environment

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PHARMACEUTICAL CHEMISTRY 4
COURSE OUTLINE

Unit III (continued...)

7. Statistical Process Control
8. Validation
8.1 Process validation
8.2 Analytical method validation
8.3 Validation of manufacturing equipment
8.4 Cleaning validation
8.5 Validation of existing products
9. Stability Studies

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