Giacomo PEPE | QUALITY CONTROL OF GALENIC PREPARATION
Giacomo PEPE QUALITY CONTROL OF GALENIC PREPARATION
cod. 0760300040
QUALITY CONTROL OF GALENIC PREPARATION
| 0760300040 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF7 | |
| PHARMACY | |
| 2024/2025 |
| YEAR OF COURSE 5 | |
| YEAR OF DIDACTIC SYSTEM 2023 | |
| SPRING SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| CHIM/08 | 6 | 48 | LESSONS |
| Objectives | |
|---|---|
| THE COURSE IS AIMED AT THE ACQUISITION OF KNOWLEDGE AND UNDERSTANDING OF THE PROCEDURES RELATED TO THE ANALYSIS AND QUALITY CONTROL OF GALENIC PRODUCTS IN RELATION TO CURRENT REGULATIONS. AT THE END OF THE COURSE THE STUDENT WILL KNOW: • THE PROCEDURES FOR THE ANALYSIS AND QUALITY CONTROL OF THE MAIN GALENICAL PRODUCTS, ACCORDING TO CURRENT REGULATIONS. • IDENTIFY, CONTROL AND MONITORING THE QUALITY OF THE GALENICAL AND MAGISTRAL PREPARATIONS AND THE MOST COMMON PHARMACEUTICAL FORMS. |
| Prerequisites | |
|---|---|
| IN ORDER TO TAKE THE QUALITY CONTROL OF GALENIC FORMULAS EXAM, THE STUDENT MUST HAVE PASSED THE EXAM OF ANALYTICAL CHEMISTRY, INTRODUCTORY LABORATORY TO DRUG ANALYSIS, DRUG ANALYSIS I AND II. |
| Contents | |
|---|---|
| LECTURES (48 HOURS- 6 ECTS ) - PRESENTATION OF THE COURSE, OFFICIAL ITALIAN PHARMACOPOEIA (F.U), EUROPEAN PHARMACOPOEIA (2 HOURS). -LEGISLATIVE REGULATIONS REGARDING THE PREPARATION, PACKAGING AND QUALITY CONTROL OF GALENICAL PREPARATIONS (2 HOURS). - GOOD PREPARATION RULES (NBP)(4 HOURS) - OBLIGATIONS TO BE CARRIED OUT BEFORE SETTING UP THE PREPARATION: COMPLIANCE WITH THE OPERATING PROCEDURE, FORMULATION AND COMPOSITION, RAW MATERIALS, CONTAINERS, ROOMS, EQUIPMENT, CLOTHING SUITABLE FOR PREPARATION (4 HOURS). - OBLIGATIONS TO BE CARRIED OUT AFTER THE SETUP OF THE PREPARATION: CORRECTNESS OF THE PROCEDURES PERFORMED, QUALITY AND QUANTITATIVE ASPECTS, STABILITY, CORRECT PACKAGING, CORRECT COMPLETION OF THE LABEL (8 HOURS). -QUALITY CONTROLS TO BE CARRIED OUT ON THE FINISHED PRODUCT, APPEARANCE, UNIFORMITY OF MASS AND CONTENT, DISGREGATION, DISSOLUTION AND RESISTANCE TO BREAKAGE TEST OF ORAL SOLID DOSAGE FORMS (6 HOURS ). -QUALITY CONTROLS TO BE CARRIED OUT ON THE FINISHED PRODUCT, PH, APPEARANCE AND ABSENCE OF PARTICLES VISIBLE TO THE NAKED EYE, DIMENSIONAL DISTRIBUTION OF PARTICLES, VISCOSITY, DENSITY, CHEMICAL STABILITY OF THE ACTIVE SUBSTANCES OF LIQUID PREPARATIONS AND DISPERSED SYSTEMS (6 HOURS ). - QUALITY CONTROLS TO BE CARRIED OUT ON THE FINISHED PRODUCT, APPEARANCE, UNIFORMITY OF MASS AND CONTENT, DISGREGATION TEST, DISSOLUTION AND SOFTENING TIME OF SUPPOSITORIES AND OVA (6 HOURS). -MICROBIAL POLLUTION OF STERILE PREPARATIONS (2 HOURS). - PROCEDURES FOR THE ANALYSIS AND QUALITY CONTROL OF THE MAIN GALENICAL PRODUCTS, ACCORDING TO CURRENT REGULATIONS (8 HOURS). |
| Teaching Methods | |
|---|---|
| THE COURSE CONSISTS INTO 48 HOURS OF THEORETICAL LESSONS (6 ECTS). THE LECTURES ARE DELIVERED IN THE CLASSROOM WITH THE AID OF PROJECTIONS AND ADDRESS ALL THE TOPICS OF THE COURSE PROGRAM. ATTENDANCE OF LESSONS IS MANDATORY. IN ORDER TO TAKE THE FINAL EXAM THE STUDENT MUST HAVE ATTENDED AT LEAST 70% OF THE HOURS SCHEDULED FOR THE COURSE. |
| Verification of learning | |
|---|---|
| THE ACHIEVEMENT OF THE COURSE OBJECTIVES IS CERTIFIED BY PASSING AN EXAM WITH A RATING OUT OF THIRTY. THE EXAM CONSISTS OF AN ORAL EXAM WHICH INCLUDES A DISCUSSION LASTING ABOUT 20 MINUTES AIMED AT ASSESSING THE LEVEL OF KNOWLEDGE AND UNDERSTANDING ABILITY REACHED BY THE STUDENT ON THE THEORETICAL AND METHODOLOGICAL CONTENTS INDICATED IN THE PROGRAM. THE ORAL TEST WILL ALSO ALLOW YOU TO VERIFY THE STUDENT'S COMMUNICATION ABILITY WITH LANGUAGE PROPERTIES AND INDEPENDENT ORGANIZATION. |
| Texts | |
|---|---|
| LA FARMACOPEA UFFICIALE ITALIANA VIGENTE. THE EUROPEAN PHARMACOPOEIA (PH. EUR.) 9TH EDITION. |
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