Francesca SANSONE | INDUSTRIAL QUALITY MANAGMENT: QUALITY ASSURANCE AND QUALITY CONTROL

cod. 0760400033

INDUSTRIAL QUALITY MANAGMENT: QUALITY ASSURANCE AND QUALITY CONTROL

	0760400033
	DIPARTIMENTO DI FARMACIA
	EQF7
	PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY
	2023/2024

PERCORSO SHARED STUDY PATHWAY

	YEAR OF DIDACTIC SYSTEM 2023
	SPRING SEMESTER

TEACHING UNITS

	SSD	CFU	HOURS	ACTIVITY	TYPE OF ACTIVITY
	CHIM/09	6	48	LESSONS	SUPPLEMENTARY COMPULSORY SUBJECTS

PROFESSORS

	FRANCESCA SANSONE T Curriculum
	GIULIA AURIEMMA Curriculum

	Objectives
	COURSE OBJECTIVES AND LEARNING OUTCOMES THE COURSE AIMS TO ACQUIRE KNOWLEDGE RELATED TO QUALITY ASSURANCE (QA) IN PHARMACEUTICAL COMPANIES AND REGULATORY REFERENCE STANDARDS, AS WELL AS SKILLS IN THE DESIGN, CONTROL, AND MANAGEMENT OF DOCUMENTATION FOR FUNDAMENTAL QA SYSTEMS TO ENSURE THE QUALITY, SAFETY, AND EFFICACY OF PHARMACEUTICAL PRODUCTS. IT ALSO PROVIDES AN OVERVIEW OF THE ORGANIZATION OF QUALITY CONTROL (QC) LABORATORIES WITHIN A QA SYSTEM, FOCUSING ON CHEMICAL AND MANUFACTURING CONTROL. KNOWLEDGE AND UNDERSTANDING AT THE END OF THE COURSE, THE STUDENT WILL KNOW: -THE REGULATORY FRAMEWORK IN THE PHARMACEUTICAL INDUSTRY, QUALITY MANAGEMENT, CONTROL, AND CERTIFICATION SYSTEMS -METHODOLOGIES FOR ANALYZING THE PRODUCTION, CONTROL, AND DISTRIBUTION PROCESSES OF PHARMACEUTICAL PRODUCTS -TOOLS FOR IMPLEMENTING QUALITY CERTIFICATION MODELS MAKING JUDGMENTS AT THE END OF THE COURSE, THE STUDENT WILL BE ABLE TO: - DESCRIBE QA PROCESSES, AND THE ORGANIZATION OF QC IN THE PHARMACEUTICAL INDUSTRY, - USE THE ACQUIRED KNOWLEDGE AND SKILLS TO ANALYZE THE QUALITY SYSTEM OF A PHARMACEUTICAL COMPANY - CRITICALLY ANALYZING ISSUES RELATED TO QUALITY MANAGEMENT ASPECTS, BOTH INSIDE AND OUTSIDE THE ORGANIZATION

COURSE OBJECTIVES AND LEARNING OUTCOMES

THE COURSE AIMS TO ACQUIRE KNOWLEDGE RELATED TO QUALITY ASSURANCE (QA) IN PHARMACEUTICAL COMPANIES AND REGULATORY REFERENCE STANDARDS, AS WELL AS SKILLS IN THE DESIGN, CONTROL, AND MANAGEMENT OF DOCUMENTATION FOR FUNDAMENTAL QA SYSTEMS TO ENSURE THE QUALITY, SAFETY, AND EFFICACY OF PHARMACEUTICAL PRODUCTS.
IT ALSO PROVIDES AN OVERVIEW OF THE ORGANIZATION OF QUALITY CONTROL (QC) LABORATORIES WITHIN A QA SYSTEM, FOCUSING ON CHEMICAL AND MANUFACTURING CONTROL.

KNOWLEDGE AND UNDERSTANDING

AT THE END OF THE COURSE, THE STUDENT WILL KNOW:
-THE REGULATORY FRAMEWORK IN THE PHARMACEUTICAL INDUSTRY,
QUALITY MANAGEMENT, CONTROL, AND CERTIFICATION SYSTEMS
-METHODOLOGIES FOR ANALYZING THE PRODUCTION, CONTROL, AND DISTRIBUTION PROCESSES OF PHARMACEUTICAL PRODUCTS
-TOOLS FOR IMPLEMENTING QUALITY CERTIFICATION MODELS

MAKING JUDGMENTS

AT THE END OF THE COURSE, THE STUDENT WILL BE ABLE TO:
- DESCRIBE QA PROCESSES, AND THE ORGANIZATION OF QC IN THE PHARMACEUTICAL INDUSTRY,
- USE THE ACQUIRED KNOWLEDGE AND SKILLS TO ANALYZE THE QUALITY SYSTEM OF A PHARMACEUTICAL COMPANY
- CRITICALLY ANALYZING ISSUES RELATED TO QUALITY MANAGEMENT ASPECTS, 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 MODULE 1: QUALITY ASSURANCE IN PHARMACEUTICAL INDUSTRY (32 TOTAL HOURS) 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 (8 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. - PRODUCTION AND QUALITY CONTROL. PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION. VALIDATION. PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCTS. PACKAGING MATERIALS. FINISHED PRODUCTS - 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 OF QA FROM DIFFERENT PHARMACEUTICAL INDUSTRIES (4 HOURS) MODULE 2: QUALITY CONTROL (16 TOTAL HOURS) 8. ORGANIZATION AND RESPONSIBILITIES IN INDUSTRIAL QUALITY CONTROL (QC) (2 HOURS OF LECTURES) 9. GOOD QUALITY CONTROL LABORATORY PRACTICE (4 HOURS) - PERSONNEL (TRAINING AND CONTRACTS), PREMISES AND EQUIPMENT - SAMPLING, SPECIFICATIONS, AND TESTING - RELEASE PROCEDURES - ON-GOING STABILITY PROGRAMME AFTER AIC (ICH RECOMMENDATIONS) (1 HOUR) 10. QC DOCUMENTATION (6 HOURS) - SPECIFICATIONS, SAMPLING AND TESTING PROCEDURES, RECORDS - PROCEDURES AND RECORDS OF THE CALIBRATION/QUALIFICATION OF INSTRUMENTS AND MAINTENANCE OF EQUIPMENT; - PROCEDURES FOR INVESTIGATING OUT OF SPECIFICATION (OOS) AND OUT OF TRAND (OOT) RESULTS; - TESTING REPORTS AND/OR CERTIFICATES OF ANALYSIS (INCLUDING DATA FROM ENVIRONMENTAL MONITORING (WHEN REQUIRED); - VALIDATION RECORDS OF TEST METHODS (WHEN REQUIRED) 11. SEMINARS WITH EXPERTS OF QC FROM DIFFERENT PHARMACEUTICAL INDUSTRIES (4 HOURS)

Contents

COURSE CONTENTS

MODULE 1: QUALITY ASSURANCE IN PHARMACEUTICAL INDUSTRY (32 TOTAL HOURS)

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 (8 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.
- PRODUCTION AND QUALITY CONTROL. PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION. VALIDATION. PROCESSING OPERATIONS: INTERMEDIATE AND BULK PRODUCTS. PACKAGING MATERIALS. FINISHED PRODUCTS
- 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 OF QA FROM DIFFERENT PHARMACEUTICAL INDUSTRIES (4 HOURS)

MODULE 2: QUALITY CONTROL (16 TOTAL HOURS)

8. ORGANIZATION AND RESPONSIBILITIES IN INDUSTRIAL QUALITY CONTROL (QC) (2 HOURS OF LECTURES)

9. GOOD QUALITY CONTROL LABORATORY PRACTICE (4 HOURS)
- PERSONNEL (TRAINING AND CONTRACTS), PREMISES AND EQUIPMENT
- SAMPLING, SPECIFICATIONS, AND TESTING
- RELEASE PROCEDURES
- ON-GOING STABILITY PROGRAMME AFTER AIC (ICH RECOMMENDATIONS) (1 HOUR)

10. QC DOCUMENTATION (6 HOURS)
- SPECIFICATIONS, SAMPLING AND TESTING PROCEDURES, RECORDS
- PROCEDURES AND RECORDS OF THE CALIBRATION/QUALIFICATION OF INSTRUMENTS AND MAINTENANCE OF EQUIPMENT; - PROCEDURES FOR INVESTIGATING OUT OF SPECIFICATION (OOS) AND OUT OF TRAND (OOT) RESULTS;
- TESTING REPORTS AND/OR CERTIFICATES OF ANALYSIS (INCLUDING DATA FROM ENVIRONMENTAL MONITORING (WHEN REQUIRED);
- VALIDATION RECORDS OF TEST METHODS (WHEN REQUIRED)

11. SEMINARS WITH EXPERTS OF QC FROM DIFFERENT PHARMACEUTICAL INDUSTRIES (4 HOURS)

	Teaching Methods
	METHODS AND DIDACTIC STRATEGIES THE 6-CREDIT COURSE (48 HOURS) WILL INCLUDE 36 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 8 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.

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

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Francesca SANSONE | INDUSTRIAL QUALITY MANAGMENT: QUALITY ASSURANCE AND QUALITY CONTROL