FRANCESCO DEL PRETE | PRODUCTION AND QUALITY ASSURANCE IN THE ANIMAL HEALTH PHARMACEUTICAL INDUSTRY
FRANCESCO DEL PRETE PRODUCTION AND QUALITY ASSURANCE IN THE ANIMAL HEALTH PHARMACEUTICAL INDUSTRY
| 0712300029 | |
| DIPARTIMENTO DI FARMACIA | |
| EQF6 | |
| PHARMACEUTICALS AND NUTRACEUTICALS FOR ANIMALS | |
| 2024/2025 |
| YEAR OF DIDACTIC SYSTEM 2022 | |
| SPRING SEMESTER |
| SSD | CFU | HOURS | ACTIVITY | |
|---|---|---|---|---|
| CHIM/09 | 6 | 48 | LESSONS |
| Objectives | |
|---|---|
| The course is aimed at acquiring knowledge on: -EU legal framework for veterinary medicines and health products, requirements for raw materials, excipients and additives intended for animals from national, EU or non-EU origin -design, control, management of quality assurance systems and company standards; the role of the QA in products’ development process in animal health industry; how to ensure a high level of products’ safety, efficacy and quality. At the end of the course the student will be able to: -describe the production and quality assurance processes in the animal health industry; -use the knowledge acquired to analyze a hypothetical quality system of an animal health company (case study) -propose strategies for improving the quality system of an animal health pharmaceutical company. |
| Prerequisites | |
|---|---|
| BASIC KNOWLEDGE OF THE TECHNOLOGICAL PHARMACEUTICAL FIELD IS RECOMMENDED. |
| Contents | |
|---|---|
| 1.INTRODUCTION TO EUROPEAN REGULATIONS ON VETERINARY MEDICINES (4 HOURS) •REGULATION (EU) 2019/6: MARKET AUTHORIZATION, MANUFACTURING, IMPORTATION, DISTRIBUTION, PHARMACOVIGILANCE. •NATIONAL AND EUROPEAN CONTEXT OF VETERINARY MEDICINAL PRODUCTS. 2.AUTHORIZATION PROCEDURE AND DOSSIER COMPOSITION (4 HOURS) •ANNEX II TO THE REGULATION: AUTHORIZATION PROCEDURE FOR PLACING ON THE MARKET. •REQUIREMENTS FOR DOSSIER COMPOSITION FOR MARKETING AUTHORIZATION (MA). 3.RAW MATERIALS AND FEED REGULATIONS (2 HOURS) •EU RECOMMENDATIONS 2011/25 ON RAW MATERIALS FOR FEED AND ADDITIVES. •DEFINITIONS OF FEED, MEDICATED FEED, AND VETERINARY MEDICINAL PRODUCT. 4.QUALITY ASSURANCE AND REGULATORY MANAGEMENT (4 HOURS) •CONCEPTS OF QUALITY IN THE PHARMACEUTICAL INDUSTRY. •ORGANIZATION OF A PHARMACEUTICAL INDUSTRY: KEY ROLES, QUALITY MANAGEMENT SYSTEMS. 5.REGULATORY PARADIGMS AND QUALITY GOVERNANCE (6 HOURS) •COMMUNITY PHARMACEUTICAL LEGISLATION AND REGULATORY GUIDELINES. •NATIONAL AND COMMUNITY HEALTH AUTHORITIES. •GOOD MANUFACTURING PRACTICE (GMP) AND AUTHORIZATION PROCEDURES. 6.INDUSTRIAL QUALITY MANAGEMENT SYSTEM (8 HOURS) •GOOD MANUFACTURING PRACTICE (GMP) - EUDRALEX VOLUME 4. •PERSONNEL MANAGEMENT, QUALIFICATION, AND TRAINING. •MANAGEMENT OF PREMISES, EQUIPMENT, AND DOCUMENTATION. •PREVENTION OF CONTAMINATION AND PROCESSING OPERATIONS. 7.QUALITY CONTROL AND GOOD LABORATORY PRACTICE (6 HOURS) •MAIN DOCUMENTATION (2H) AND LABORATORY PRACTICE (4H). 8.GOOD DISTRIBUTION PRACTICES AND RISK MANAGEMENT (4 HOURS) •GOOD DISTRIBUTION PRACTICES (GDP). •RISK MANAGEMENT IN VETERINARY GMP AND GDP. 9.TECHNICAL STANDARDS AND NEW QUALITY PARADIGMS (2 HOURS) •UNI EN ISO TECHNICAL STANDARDS AND NEW ICH QUALITY PARADIGMS. 10.IN-DEPTH SEMINARS WITH INDUSTRY EXPERTS (8 HOURS) •MEETINGS WITH EXPERTS FROM COMPANIES IN THE NATIONAL TERRITORY TO DELVE INTO SPECIFIC TOPICS. |
| Teaching Methods | |
|---|---|
| THE COURSE CONSISTS OF 48 HOURS (6 CFU) OF LECTURES DIVIDED INTO 36 HOURS OF FRONTAL TEACHING, 4 HOURS OF PRACTICAL EXERCISES IN SMALL GROUPS, AND 8 HOURS OF SEMINAR ACTIVITIES. |
| Verification of learning | |
|---|---|
| THE ACHIEVEMENT OF THE LEARNING OBJECTIVES WILL BE ASSESSED THROUGH BOTH A WRITTEN AND AN ORAL EXAM. THE WRITTEN EXAM, LASTING 60 MINUTES, WILL COMPRISE A STRUCTURED TEST CONSISTING OF 18 MULTIPLE-CHOICE QUESTIONS, EACH WITH ONLY ONE CORRECT ANSWER, AND 3 OPEN-ENDED QUESTIONS. THESE QUESTIONS WILL COVER THE ENTIRE COURSE CURRICULUM. THE SCORING FOR THE WRITTEN EXAM WILL BE AS FOLLOWS: EACH CORRECT ANSWER FOR THE 18 MULTIPLE-CHOICE QUESTIONS WILL EARN 1 POINT. INCORRECT ANSWERS WILL RECEIVE A SCORE OF 0. FOR THE 3 OPEN-ENDED QUESTIONS, A MAXIMUM SCORE OF 4 POINTS, FOR EACH QUESTION, CAN BE AWARDED. THE EVALUATION OF THE WRITTEN TEST IS OUT OF THIRTY AND PASSING IT IS A PREREQUISITE FOR THE ORAL EXAMINATION. THE ORAL EXAM WILL INVOLVE DISCUSSING THE WRITTEN TEST AND ADDRESSING QUESTIONS RELATED TO THE COURSE TOPICS. THE STUDENT'S ABILITY TO ENGAGE WITH THE TOPICS IN A COMPREHENSIVE AND CRITICAL MANNER WILL BE ASSESSED. THE EVALUATION OF THE ORAL TEST IS ALSO OUT OF THIRTY. THE FINAL GRADE WILL BE DETERMINED BY THE WEIGHTED AVERAGE OF THE SCORES FROM BOTH EXAMS (WRITTEN + ORAL). |
| Texts | |
|---|---|
| REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 11 DECEMBER 2018 ON VETERINARY MEDICINAL PRODUCTS AND REPEALING DIRECTIVE 2001/82/EC; REGULATION (EU) 2019/4 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 11 DECEMBER 2018 ON THE MANUFACTURE, PLACING ON THE MARKET, AND USE OF MEDICATED FEED, AMENDING REGULATION (EC) NO 183/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL AND REPEALING COUNCIL DIRECTIVE 90/167/EEC; EUDRALEX VOLUME 4. GUIDELINES THE RULES GOVERNING MEDICINAL PRODUCTS IN THE EUROPEAN UNION VOLUME 4 EU GUIDELINES FOR GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN AND VETERINARY USE |
| More Information | |
|---|---|
| LANGUAGE OF TEACHING: ITALIAN; LOCATION OF THE LECTURES: DEPARTMENT OF PHARMACY; FOR FURTHER INFORMATION CONTACT THE TEACHER: FDELPRETE@UNISA.IT |
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