PHR 525 – Analytical Quality Control

• Prof. Dr. Sobhi Soliman
• Dr. Karin Magdi Guirguis

• T.A. Maram Yasser
• T.A. Menna Hadad

This course gives an introduction to the principles of quality assurance&quality control of drug product, validation of analytical procedures, equipment qualification, drug degradation and sampling in pharmaceutical analysis.

The Analytical Quality Control is concerned with the following topics: • Quality assurance (QA), quality control (QC), good analytical practice (GAP), good laboratory practice (GLP) and good quality management (GQM). • Sampling basis, sampling procedures, sampling tools and protocols for sample preparation. • Validation and revalidation of analytical procedures. • Validation characteristics: accuracy, precision, repeatability, intermediate precision, reproducibility, linearity, range, detection limit, quantitation limit, specificity, robustness, ruggedness and system suitability testing. • Equipment qualification involving design, installation, operational and performance qualifications. • Pharmacopeial calibration and standardization of analytical instruments. • Documentation, reference standards, good chemical storage and hazard avoidance. • Routes of drug degradation, stability indicating assay methods, forced degradation and stress testing.

Assessment Form % Grades -Mid-term: 20% 60 marks -Practical 17 % 50 marks – Interactive learning 13 % 40 marks -Final exam: 40 % 120 marks -Oral exam: 10% 30 marks

1. Handbook of Modern Pharmaceutical Chemistry Academic Press ISB N(0-12-045555), 2000.
2. The British Pharmacopoeia 2015 (set 5 volumes) + Veterinary USB flash. TSO – Stationery Office, London, UK (2015).
3. Sethi. HPTLC: Quantitative analysis of pharmaceutical formulation (set 3 volumes) 2013, CBS publisher.
4. Christopher A. Langley and Dawn Belcher. Applied pharmaceutical practice (Fasttrach) 2nd edition pharmaceutical press 2012.

1. The United States Pharmacopeia, Thirty-fifth edition, The National Formulary, Thirty edition, United States Pharmacopeial Convention, Inc. , Asian Edition, Washington, D.C. (2012).
2. The British Pharmacopoeia, Her Majesty’s Stationery Office, London (2016). 3. ICH, Validation of Analytical Procedures: Text and Methodology Q2(R1), International Conference on Harmonisation, Geneva, (2005).