Description

(I) Quality control & quality assurance of pharmaceuticals: The course has to be 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 standard pharmacopeial methods and procedures as well as international guidelines as WHO, EMA, TGA should be discussed (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

Objectives

• Domain (1): Fundamental knowledge By the end of the course the student should be able to: 1.1 Demonstrate the fundamental concepts of Good Manufacturing Practice, GMP, differential concepts of Quality control versus Quality Assurance. 1.2. Recognize basis of System Suitability Testing for chromatoghic and spectroscopic analytical techniques. 1.3. Discuss the stability profile of drug substance and drug product. 1.4. Display the basic guidelines for analytical method validation, according to international organizations. Domain (2): Professional and Ethical Practice At the end of the course the student should be able to: 2.1 Analyze different pharmaceutical products concerning the topics of the course in a systematic way. 2.2 Detect and validate the method of analysis and sampling techniques. 2.3 Recognize the possible degradation pathways with regard to chemical structure of pharmaceutical compound and excipients. 2.4 Handle and dispose hazardous materials used in the pharmaceutical field according to safety measures and estimate shelf life of pharmaceuticals. Domain (3): Pharmaceutical Care At the end of the course the student should be able to: 3.1 Integrate the knowledge of chemical compounds including the physical and chemical properties to properly analyze different materials and handle chemicals according to the encountered hazards. Domain (4): Personal Practice At the end of the course the student should be able to: 4.1 Demonstrate responsibility for team performance and express time management skills. 4.2 Retrieve and critically analyze information, identify and solve problems, and work autonomously and effectively in a team. 4.3 Use new technologies and media to demonstrate effective presentation skills. 4.4 Practice independent learning needed for continuous professional development.