GENERAL OBJECTIVES

Upon successful completion of this course, the student will be able to:

1. Remember key regulatory frameworks and quality standards, including the roles of pharmacopoeias (Ph. Eur., USP, JP), ICH guidelines, and Good Manufacturing Practices (GMP).

2. Explain the fundamental principles and essential validation parameters (e.g., accuracy, precision, specificity) that ensure the reliability of pharmaceutical analytical methods.

3. Apply standard pharmacopoeial procedures to perform fundamental physical and chemical analyses.

4. Analyze complex pharmaceutical samples by selecting and utilizing appropriate chromatographic (e.g., HPLC, GC) and spectroscopic (e.g., UV-Vis, IR, AAS) techniques for separation and identification.

5. Differentiate between the roles and responsibilities of Quality Assurance (QA) and Quality Control (QC) and how they integrate within a pharmaceutical quality management system.

6. Evaluate the quality of raw materials, in-process samples, and finished products by interpreting analytical data against established specifications to make release or rejection decisions.