Description

The course is designed for quality control, quality assurance or regulatory affairs personnel who have responsibility for the performance of methods and procedures of different quality control tests used for evaluation of safety and potency of pharmaceutical products. The course involves I-Quality control & quality assurance of pharmaceuticals, standard pharmacopeial methods and procedures as well as international guidelines as WHO, EMA, TGA; II-Good Analytical Practice and Sampling: Introduction, Sampling of pharmaceuticals and related materials, Type of sampling tools, Sampling plans. III-Documentation; IV- Validation of analytical methods according to ICH Guidelines Q2 R1. Compendial testing, Validation of analytical methods, Data elements required for assay validation; V- Drug stability, stability studies and stability indicating methods Drug stability, Stability testing, forced degradation studies, stability indicating assay methods for drugs according to ICH Q1 R2 Guidelines. Stress conditions for drug degradation according to ICH Q1 R2 Guidelines. Factors affecting drug degradation, Drug expiration, Drug withdrawal from the market. Pharmaceutical regulations according to FDA & EMA (European Medicine Agency) and ISO and BSI. Drug-excipient interactions and adduct formation; analytical techniques used to detect drug-excipient compatibility, mechanism of drug-excipient interactions, examples; VI- Official methods of analysis applied to raw materials and end products.

Program

PharmD Clinical

Objectives

• Intended Learning Outcomes Knowledge and Understanding By the end of the course, the students should be able to: a.1. Describe different methods for QC assessment of pharmaceuticals. a.2. Outline the general procedures for validation of the analysis method according to ICH guidelines. a.3. Explain the basic concepts of Good Laboratory Procedure (GLP), Quality Control (QC) and Quality Assurance (QA). a.4. Outline the System Suitability Testing (SST); concept and applications. a.5. Illustrate the Stability Indicating Methods (SIAMs) as well as Stability Drug Profile. Intellectual Skills By the end of the course, the students should be able to: b.1. Apply pharmacopeia methods of stability and stability testing of the drugs. b.2. Organize data and documentation coupled with a working knowledge of relevant statistical methods. b.3. Evaluate QC and validation methods. Professional and Practical skills By the end of the course, the students should be able to: c.1. Apply standard laboratory skills and techniques required for quality control analysis of different market drugs. c.2. Handle chemicals and carry out standard laboratory analytical procedures safely. c.3. Manipulate statistical data of test results for the developed analytical methods using EXCEL. c.4. Acquire the capabilities of different Sampling techniques for drug substances. General and Transferable skills By the end of the course, the students should be able to: d.1. Manage time properly. d.2. Adopt self-learning. d.3. Evaluate the results obtained from the practical work. d.4. Develop decision making skills to deal with different problems.