Francesca SANSONE | QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY
Francesca SANSONE QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY
cod. 0760200031
QUALITY ASSURANCE IN THE PHARMACEUTICAL INDUSTRY
| 0760200031 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF7 | |
| PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY | |
| 2023/2024 |
| YEAR OF COURSE 5 | |
| YEAR OF DIDACTIC SYSTEM 2016 | |
| SPRING SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| CHIM/09 | 5 | 40 | LESSONS |
| Objectives | |
|---|---|
| COURSE OBJECTIVES AND LEARNING OUTCOMES THE AIM OF THE COURSE IS TO PROVIDE STUDENTS A SET OF INSTRUMENTS AND METHODOLOGIES TO UNDERSTAND PRINCIPLES AND FEATURES OF A PHARMACEUTICAL INDUSTRY, PARTICULARLY IN RELATION TO QUALITY ASSURANCE ASPECTS. AT THE END OF THE COURSE, STUDENTS MUST HAVE ACQUIRED KNOWLEDGE, SKILLS AND COMPETENCES USEFUL FOR THE MANAGEMENT OF QUALITY IN A PHARMACEUTICAL INDUSTRY. KNOWLEDGE AND UNDERSTANDING SKILLS - KNOWLEDGE OF PHARMACEUTICAL INDUSTRY REGULATIONS – KNOWLEDGE OF SYSTEMS AND INSTRUMENTS FOR MANAGEMENT, CONTROL, AND QUALITY CERTIFICATION - KNOWLEDGE OF METHODS FOR THE ANALYSIS OF PRODUCTION, CONTROL AND DISTRIBUTION OF PHARMACEUTICAL PRODUCTS - KNOWLEDGE OF METHODS AND INSTRUMENTS FOR IMPLEMENTING MODELS OF QUALITY CERTIFICATION. KNOWLEDGE AND APPLIED SKILLS - ABILITY TO USE THE ACQUIRED KNOWLEDGE FOR THE MANAGEMENT OF DIFFERENT PRODUCTION FACTORS. - ABILITY TO EVALUATE THE IMPACT OF DIFFERENT MODELS/APPROACHES ON QUALITY CERTIFICATION - ABILITY TO MANAGE COMPLEX SITUATIONS FOR THE IMPLEMENTATION, AND SUBSEQUENT CERTIFICATION, OF PHARMACEUTICAL QUALITY SYSTEMS - ABILITY TO COMMUNICATE AND EXPRESS PROBLEMS CONCERNING THE MANAGEMENT OF QUALITY, BOTH INSIDE AND OUTSIDE THE ORGANIZATION |
| Prerequisites | |
|---|---|
| PREREQUISITES AND PROPAEDEUTICS THE COURSE HAS NO SPECIFIC PREREQUISITES. HOWEVER, BASIC KNOWLEDGE RELATED TO THE FOLLOWING IS RECOMMENDED: - PREPARATION AND CONTROL OF PHARMACEUTICAL PRODUCTS - FACILITIES AND EQUIPMENT OF A PHARMACEUTICAL INDUSTRY. |
| Contents | |
|---|---|
| COURSE CONTENTS 1. INTRODUCTION TO QUALITY ASSURANCE (QA) IN THE PHARMACEUTICAL INDUSTRY (2 HOURS OF LECTURES) - ORGANIZATION OF A PHARMACEUTICAL INDUSTRY, PERSONNEL, AND KEY ROLES (PRODUCTION, QUALITY CONTROL, QUALITY ASSURANCE, PHARMACOVIGILANCE, REGULATORY AFFAIRS) - QUALITY CONCEPTS IN THE PHARMACEUTICAL INDUSTRY - MAIN COMPONENTS OF A QUALITY MANAGEMENT SYSTEM (QMS) 2. REGULATORY PARADIGMS OF GOVERNANCE AND QUALITY MANAGEMENT (8 HOURS OF LECTURES) - EUROPEAN PHARMACEUTICAL LEGISLATION, REGULATORY GUIDANCE AND RELATED DOCUMENTS - NATIONAL AND EUROPEAN HEALTH AUTHORITIES. REGULATORY AGENCIES (AIFA, EMA, FDA) - INTRODUCTION TO GOOD MANUFACTURING PRACTICES (GMP) AUTHORIZATION FOR MANUFACTURING AND MARKETING OF A MEDICINAL PRODUCT (AUTHORIZATION PROCEDURES) 3.QUALITY MANAGEMENT SYSTEM IN INDUSTRIAL PRODUCTION OF MEDICINES (14 HOURS OF LECTURES) - GOOD MANUFACTURING PRACTICES (GMP) - EUDRALEX VOLUME 4 - PHARMACEUTICAL QUALITY SYSTEM - PERSONNEL AND ORGANIZATION. PERSONNEL QUALIFICATION. TRAINING. “QUALIFIED PERSON” ETC. - PREMISES AND EQUIPMENT: PRODUCTION AREAS, QUALITY CONTROL, STORAGE. DESIGN, CONSTRUCTION, USE, MAINTENANCE, ACCESS, ETC - DOCUMENT MANAGEMENT SYSTEM. MANAGEMENT OF DOCUMENTATION. STANDARD OPERATIVE PROCEDURES (SOP). MASTER BATCH RECORD (MBR). BATCH RECORD (BR). SITE MASTER FILE (SMF), ETC. - MAIN QUALITY CONTROL DOCUMENTATION - PRODUCTION. PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION. VALIDATION. PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCTS. PACKAGING MATERIALS. FINISHED PRODUCTS - QUALITY CONTROL: GOOD PRACTICE AND MAIN DOCUMENTATION - INSPECTIONS - MANAGEMENT OF CHANGES, DEVIATIONS, AND NON-CONFORMITIES (CAPA) 4. UNI EN ISO STANDARDS (3 HOURS OF LECTURES) 5. NEW QUALITY PARADIGMS (2 HOURS OF LECTURES) - ICH Q8 (QUALITY BY DESIGN), ICH-Q9 (QUALITY RISK MANAGEMENT) AND ICH Q10 (PHARMACEUTICAL QUALITY SYSTEMS) 6. IN-DEPTH STUDY OF ANNEXES OF EUDRALEX VOLUME 4 (1 HOUR OF LECTURES + 4 HOURS OF CLASSROOM PROJECT ACTIVITIES) 7. SEMINARS WITH EXPERTS FROM DIFFERENT PHARMACEUTICAL INDUSTRIES (6 HOURS) |
| Teaching Methods | |
|---|---|
| METHODS AND DIDACTIC STRATEGIES THE 5-CREDIT COURSE (40 HOURS) WILL INCLUDE 30 HOURS OF LECTURES COVERING THE TOPICS AS DESCRIBED, 4 HOURS OF IN-CLASS PRACTICE WITH STUDY OR WORK GROUPS RELATED TO THE MENTIONED TOPICS, AND 6 HOURS OF SEMINARS AND INTERACTION WITH THE TEACHER AND/OR EXPERTS IN THE FIELD. |
| Verification of learning | |
|---|---|
| ASSESSMENT OF STUDENT LEARNING STUDENT LEARNING WILL BE ASSESSED THROUGH BOTH A WRITTEN AND AN ORAL EXAM, WITH EVALUATION EXPRESSED IN THIRTIETHS. TO TAKE THE ORAL EXAM, STUDENTS MUST FIRST PASS THE WRITTEN EXAM WITH A MINIMUM MARK OF 18/30. THE WRITTEN EXAM WILL CONSIST OF 20 QUESTIONS AND LAST A MAXIMUM OF 90 MINUTES, AIMED AT EVALUATING KNOWLEDGE AND SKILLS. THE ORAL EXAM WILL EVALUATE THEORETICAL KNOWLEDGE, AUTONOMY OF ANALYSIS, AND THE ABILITY TO APPLY THE CONCEPTS TO PRACTICAL SCENARIOS. THE FINAL EVALUATION WILL BE THE AVERAGE OF THE PARTIAL GRADES. STUDENTS WHO DEMONSTRATE ONLY A FRAGMENTARY KNOWLEDGE AND A LIMITED CAPACITY TO APPLY THE CONCEPTS WILL RECEIVE A MINIMUM MARK OF 18/30. STUDENTS WHO DEMONSTRATE A COMPLETE KNOWLEDGE OF THE METHODOLOGIES AND A NOTABLE ABILITY TO APPLY THE CONCEPTS WILL RECEIVE A MAXIMUM MARK OF 30/30. THE HIGHEST PRAISE WILL BE RESERVED FOR THOSE STUDENTS WHO DEMONSTRATE A SIGNIFICANT MASTERY OF THE METHODOLOGIES AND A HIGH ABILITY TO APPLY THE CONCEPTS. |
| Texts | |
|---|---|
| RECOMMENDED BOOKS - EU LEGISLATION – EUDRALEX (LINK HTTP://EC.EUROPA.EU/HEALTH/DOCUMENTS/EUDRALEX/INDEX_EN.HTM) - LEGISLAZIONE FARMACEUTICA DI: PAOLA MINGHETTI. DECIMA EDIZIONE. CEA CASA EDITRICE AMBROSIANA - PRINCIPI DI TECNOLOGIA FARMACEUTICA. PAOLO COLOMBO, FRANCO ALHAIQUE, CARLA CARAMELLA, BICE CONTI, ANDREA GAZZANIGA, ELENA VIDALE - SECONDA EDIZIONE. CASA EDITRICE AMBROSIANA. ZANICHELLI |
| More Information | |
|---|---|
| NONE. |
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