Amalia PORTA | CHEMICAL AND MICROBIOLOGICAL METHODS FOR DRUGS QUALITY ASSESSMENT

cod. 0760400037

CHEMICAL AND MICROBIOLOGICAL METHODS FOR DRUGS QUALITY ASSESSMENT

	0760400037
	DIPARTIMENTO DI FARMACIA
	EQF7
	PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY
	2024/2025

PERCORSO SHARED STUDY PATHWAY

	YEAR OF COURSE 4
	YEAR OF DIDACTIC SYSTEM 2023
	AUTUMN SEMESTER

TEACHING UNITS

	SSD	CFU	HOURS	ACTIVITY	TYPE OF ACTIVITY
1	METODOLOGIE ANALITICHE PER IL CONTROLLO DI QUALITÀ MODULO DI METODOLOGIE ANALITICHE E CONTROLLO MICROBIOLOGICO DEI FARMACI
	CHIM/01	3	24	LESSONS	SUPPLEMENTARY COMPULSORY SUBJECTS
2	CONTROLLO MICROBIOLOGICO DEI FARMACI MODULO DI METODOLOGIE ANALITICHE E CONTROLLO MICROBIOLOGICO DEI FARMACI
	BIO/19	3	24	LESSONS	SUPPLEMENTARY COMPULSORY SUBJECTS

PROFESSORS

	CARLO CRESCENZI1 T Curriculum
	AMALIA PORTA2 Curriculum

	Objectives
	THE COURSE AIMS TO PROVIDE THE STUDENT WITH THE KNOWLEDGE, BOTH ON A PRACTICAL AND THEORETICAL LEVEL, OF METHODOLOGICAL APPROACHES, TRADITIONAL AND NON-TRADITIONAL, USEFUL IN QUALITY AND SAFETY CONTROLS IN DRUG PRODUCTION PROCESSES BOTH FROM A CHEMICAL AND MICROBIOLOGICAL POINT OF VIEW. BY THE END OF THE COURSE THE STUDENT WILL KNOW: - THE MAIN PROBLEMS AND THE MOST CRITICAL ASPECTS IN QUALITY ASSURANCE, - THE STATISTICAL METHODS ESSENTIAL FOR THE CONTROL OF THE POSSIBLE SOURCES OF VARIABILITY OF PHARMACEUTICAL PRODUCTS; - THE BASICS OF MULTIVARIATE ANALYSIS METHODS AND OF THE EXPERIMENTAL DESIGN NECESSARY FOR THE CORRECT SETTING OF SAMPLING AND OF THE MOST COMMONLY USED ANALYSIS TECHNIQUES; - CONVENTIONAL AND INNOVATIVE CONTROL STRATEGIES FOR MICROORGANISMS; - THE METHODS OF ENUMERATION AND IDENTIFICATION OF MICROORGANISMS; THE PRACTICAL LABORATORY EXERCISES WILL BE USED TO ACQUIRE SKILLS ON THE MAIN MICROBIOLOGICAL TECHNIQUES USED FOR DIAGNOSTIC AND RESEARCH PURPOSES.. BY THE END OF THE COURSE THE STUDENT WILL BE ABLE TO EVALUATE AND APPLY THE MOST APPROPRIATE CHEMICAL AND MICROBIOLOGICAL ANALYSIS METHODS REQUIRED BY NATIONAL, COMMUNITY AND INTERNATIONAL REGULATIONS, NECESSARY TO ASCERTAIN BOTH IN THE PREPARATION PHASE AND ON THE FINISHED PRODUCT, COMPLIANCE WITH THE STANDARDS OF GOOD MANUFACTURE OF PHARMACEUTICAL AND GALENIC PREPARATIONS.

THE COURSE AIMS TO PROVIDE THE STUDENT WITH THE KNOWLEDGE, BOTH ON A PRACTICAL AND THEORETICAL LEVEL, OF METHODOLOGICAL APPROACHES, TRADITIONAL AND NON-TRADITIONAL, USEFUL IN QUALITY AND SAFETY CONTROLS IN DRUG PRODUCTION PROCESSES BOTH FROM A CHEMICAL AND MICROBIOLOGICAL POINT OF VIEW.
BY THE END OF THE COURSE THE STUDENT WILL KNOW:
- THE MAIN PROBLEMS AND THE MOST CRITICAL ASPECTS IN QUALITY ASSURANCE,
- THE STATISTICAL METHODS ESSENTIAL FOR THE CONTROL OF THE POSSIBLE SOURCES OF VARIABILITY OF PHARMACEUTICAL PRODUCTS;
- THE BASICS OF MULTIVARIATE ANALYSIS METHODS AND OF THE EXPERIMENTAL DESIGN NECESSARY FOR THE CORRECT SETTING OF SAMPLING AND OF THE MOST COMMONLY USED ANALYSIS TECHNIQUES;
- CONVENTIONAL AND INNOVATIVE CONTROL STRATEGIES FOR MICROORGANISMS;
- THE METHODS OF ENUMERATION AND IDENTIFICATION OF MICROORGANISMS;
THE PRACTICAL LABORATORY EXERCISES WILL BE USED TO ACQUIRE SKILLS ON THE MAIN MICROBIOLOGICAL TECHNIQUES USED FOR DIAGNOSTIC AND RESEARCH PURPOSES..
BY THE END OF THE COURSE THE STUDENT WILL BE ABLE TO EVALUATE AND APPLY THE MOST APPROPRIATE CHEMICAL AND MICROBIOLOGICAL ANALYSIS METHODS REQUIRED BY NATIONAL, COMMUNITY AND INTERNATIONAL REGULATIONS, NECESSARY TO ASCERTAIN BOTH IN THE PREPARATION PHASE AND ON THE FINISHED PRODUCT, COMPLIANCE WITH THE STANDARDS OF GOOD MANUFACTURE OF PHARMACEUTICAL AND GALENIC PREPARATIONS.

	Prerequisites
	IT IS REQUIRED THE ACQUISITION OF THE OBJECTIVES RELATED TO: MICROBIOLOGY AND PATHOLOGY; AND PHYSICAL METHODS IN ORGANIC CHEMISTRY, CHEMICAL-PHARMACEUTICAL ANALYSIS II

	Contents
	THE COURSE IS DIVIDED INTO TWO MODULES: MODULE OF “ANALYTICAL TECHNIQUES AND QUALITY CONTROL” (24 H, 3 CFU)AND MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES” (24 H, 3 CFU) FOR A TOTAL OF 48H OF LECTURES (6 CFU). MODULE OF "ANALYTICAL METHODOLOGIES FOR QUALITY CONTROL" INSTRUMENTATION AND QUALITY CONTROL STATISTICAL FOUNDATIONS FOR QUALITY CONTROL. GOOD LABORATORY PRACTICES (GLP). CERTIFIED REFERENCE MATERIALS. VALIDATION OF AN ANALYTICAL METHOD. CONTROL CHARTS (6 HOURS). SAMPLING AND SAMPLE PREPARATION, SELECTION OF THE ANALYTICAL METHOD; FIGURES OF MERIT (6 HOURS). INTRODUCTION TO MULTIVARIATE ANALYSIS METHODS AND EXPERIMENTAL DESIGN, ANALYSIS AND REPRESENTATION OF EXPERIMENTAL DATA (6 HOURS)." MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES”: BASIC MICROBIOLOGICAL TECHNIQUES: CULTURE MEDIA, STERILIZATION TECHNIQUES; GRAM STAINING; MICROBIAL PLATING TECHNIQUES; BACTERIAL AND FUNGAL ISOLATION AND COUNT; CHALLENGE TEST AND SHELF-LIFE (18 HOURS); HACCP SYSTEM (HAZARD ANALYSIS AND CRITICAL CONTROL POINT) (3 HOURS); GOOD MANUFACTURING PRACTICE (GMP) REQUIREMENTS FOR FINISHED PHARMACEUTICALS AND ACTIVE PHARMACEUTICAL INGREDIENTS (APIS) (3 HOURS);

Contents

THE COURSE IS DIVIDED INTO TWO MODULES: MODULE OF “ANALYTICAL TECHNIQUES AND QUALITY CONTROL” (24 H, 3 CFU)AND MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES” (24 H, 3 CFU) FOR A TOTAL OF 48H OF LECTURES (6 CFU).
MODULE OF "ANALYTICAL METHODOLOGIES FOR QUALITY CONTROL"
INSTRUMENTATION AND QUALITY CONTROL
STATISTICAL FOUNDATIONS FOR QUALITY CONTROL. GOOD LABORATORY PRACTICES (GLP). CERTIFIED REFERENCE MATERIALS. VALIDATION OF AN ANALYTICAL METHOD. CONTROL CHARTS (6 HOURS).
SAMPLING AND SAMPLE PREPARATION, SELECTION OF THE ANALYTICAL METHOD; FIGURES OF MERIT (6 HOURS).
INTRODUCTION TO MULTIVARIATE ANALYSIS METHODS AND EXPERIMENTAL DESIGN, ANALYSIS AND REPRESENTATION OF EXPERIMENTAL DATA (6 HOURS)."
MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES”:
BASIC MICROBIOLOGICAL TECHNIQUES: CULTURE MEDIA, STERILIZATION TECHNIQUES; GRAM STAINING; MICROBIAL PLATING TECHNIQUES; BACTERIAL AND FUNGAL ISOLATION AND COUNT; CHALLENGE TEST AND SHELF-LIFE (18 HOURS);
HACCP SYSTEM (HAZARD ANALYSIS AND CRITICAL CONTROL POINT) (3 HOURS);
GOOD MANUFACTURING PRACTICE (GMP) REQUIREMENTS FOR FINISHED PHARMACEUTICALS AND ACTIVE PHARMACEUTICAL INGREDIENTS (APIS) (3 HOURS);

	Teaching Methods
	MODULE OF "ANALYTICAL METHODOLOGIES FOR QUALITY CONTROL" THE COURSE INCLUDES LECTURES ON ALL COURSE TOPICS, TOTALING 8 HOURS (1 CFU). DATA ANALYSIS WILL BE CONDUCTED IN THE CLASSROOM USING SPECIFIC SOFTWARE (1 CFU). FINALLY, A SPECIFIC EXAMPLE OF THE APPLICATION OF THE METHODS PRESENTED WILL BE ADDRESSED IN THE LABORATORY (1 CFU). MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES”: THE COURSE INCLUDES LECTURES FOR A TOTAL OF 8 HOURS (1 CFU), WHICH TAKE PLACE IN THE CLASSROOM WITH THE HELP OF POWERPOINT PROJECTIONS. IN ADDITION, LABORATORY EXERCISES WILL BE CARRIED OUT, FOR A TOTAL OF 16 HOURS IN TOTAL (2 CFU), ON STERILIZATION AND MICROBIAL COUNTING TECHNIQUES AND MEASUREMENT OF MICROBIAL GROWTH (DETERMINATION OF MPN) AND ON THE IDENTIFICATION AND MICROBIAL COUNT.

Teaching Methods

MODULE OF "ANALYTICAL METHODOLOGIES FOR QUALITY CONTROL"
THE COURSE INCLUDES LECTURES ON ALL COURSE TOPICS, TOTALING 8 HOURS (1 CFU).
DATA ANALYSIS WILL BE CONDUCTED IN THE CLASSROOM USING SPECIFIC SOFTWARE (1 CFU).
FINALLY, A SPECIFIC EXAMPLE OF THE APPLICATION OF THE METHODS PRESENTED WILL BE ADDRESSED IN THE LABORATORY (1 CFU).

MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES”:
THE COURSE INCLUDES LECTURES FOR A TOTAL OF 8 HOURS (1 CFU), WHICH TAKE PLACE IN THE CLASSROOM WITH THE HELP OF POWERPOINT PROJECTIONS. IN ADDITION, LABORATORY EXERCISES WILL BE CARRIED OUT, FOR A TOTAL OF 16 HOURS IN TOTAL (2 CFU), ON STERILIZATION AND MICROBIAL COUNTING TECHNIQUES AND MEASUREMENT OF MICROBIAL GROWTH (DETERMINATION OF MPN) AND ON THE IDENTIFICATION AND MICROBIAL COUNT.

	Verification of learning
	MODULE OF ANALYTICAL METHODOLOGIES FOR QUALITY CONTROL" THE ACHIEVEMENT OF THE TEACHING OBJECTIVES IS CERTIFIED THROUGH THE PASSING OF A SINGLE EXAMINATION WITH A GRADING SCALE FROM 1 TO 30. THE EXAMINATION CONSISTS OF AN ORAL TEST LASTING 20-30 MINUTES. DURING THE TEST, STUDENTS WILL BE REQUIRED TO APPLY THE THEORETICAL PRINCIPLES AND DATA ANALYSIS TECHNIQUES TO SOME REPRESENTATIVE CASES THAT ARE COMMON IN THE PHARMACEUTICAL INDUSTRY MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES”: THE ACHIEVEMENT OF THE OBJECTIVES OF THE COURSE IS CERTIFIED BY PASSING A SINGLE EXAM WITH EVALUATION IN THIRTIETHS. THE EXAM INCLUDES AN ORAL TEST LASTING 20-30 MIN. THE MINIMUM MARK FOR PASSING THE EXAM IS 18/30 AND WILL BE ATTRIBUTED TO THE STUDENT WHO SHOWS KNOWLEDGE OF HACCP NOTIONS AND BASIC MICROBIOLOGICAL TECHNIQUES. THE MAXIMUM GRADE OF 30/30 WILL BE ATTRIBUTED TO STUDENTS WHO DEMONSTRATE TO HAVE COMPLETE MASTERY OF THE ROLE PLAYED BY DIFFERENT MICROBIAL GROUPS WITHIN A SPECIFIC PRODUCT, PROVING THAT THEY ARE ABLE TO INDEPENDENTLY APPLY KNOWLEDGE AND SKILLS ACQUIRED EVEN IN CONTEXTS OTHER THAN THOSE PROPOSED IN CLASS. THE FINAL GRADE FOR THE INTEGRATED EXAM WILL BE THE AVERAGE OF THE RESULTS OBTAINED IN THE MODULES.

Verification of learning

MODULE OF ANALYTICAL METHODOLOGIES FOR QUALITY CONTROL" THE ACHIEVEMENT OF THE TEACHING OBJECTIVES IS CERTIFIED THROUGH THE PASSING OF A SINGLE EXAMINATION WITH A GRADING SCALE FROM 1 TO 30. THE EXAMINATION CONSISTS OF AN ORAL TEST LASTING 20-30 MINUTES. DURING THE TEST, STUDENTS WILL BE REQUIRED TO APPLY THE THEORETICAL PRINCIPLES AND DATA ANALYSIS TECHNIQUES TO SOME REPRESENTATIVE CASES THAT ARE COMMON IN THE PHARMACEUTICAL INDUSTRY

MODULE OF “MICROBIOLOGICAL CONTROL OF DRUG PRODUCTION PROCESSES”:
THE ACHIEVEMENT OF THE OBJECTIVES OF THE COURSE IS CERTIFIED BY PASSING A SINGLE EXAM WITH EVALUATION IN THIRTIETHS.
THE EXAM INCLUDES AN ORAL TEST LASTING 20-30 MIN. THE MINIMUM MARK FOR PASSING THE EXAM IS 18/30 AND WILL BE ATTRIBUTED TO THE STUDENT WHO SHOWS KNOWLEDGE OF HACCP NOTIONS AND BASIC MICROBIOLOGICAL TECHNIQUES. THE MAXIMUM GRADE OF 30/30 WILL BE ATTRIBUTED TO STUDENTS WHO DEMONSTRATE TO HAVE COMPLETE MASTERY OF THE ROLE PLAYED BY DIFFERENT MICROBIAL GROUPS WITHIN A SPECIFIC PRODUCT, PROVING THAT THEY ARE ABLE TO INDEPENDENTLY APPLY KNOWLEDGE AND SKILLS ACQUIRED EVEN IN CONTEXTS OTHER THAN THOSE PROPOSED IN CLASS.
THE FINAL GRADE FOR THE INTEGRATED EXAM WILL BE THE AVERAGE OF THE RESULTS OBTAINED IN THE MODULES.

	Texts
	HARRIS DANIEL C. CHIMICA ANALITICA QUANTITATIVA, ZANICHELLI. SKOOG D. A, WEST D. M. & HOLLER F. J., FONDAMENTI DI CHIMICA ANALITICA, EDISES. DAVID HARVEY, ANALYTICAL CHEMISTRY 2.1 , HTTPS://CHEM.LIBRETEXTS.ORG/BOOKSHELVES/ANALYTICAL_CHEMISTRY MICROBIOLOGIA ALIMENTARE APPLICATA COCOLIN, GOBBETTI, NEVIANI AMBROSIANA (ZANICHELLI) LABORATORIO DI MICROBIOLOGIA E BIOCHIMICA FABIO FANTI ZANICHELLI

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Amalia PORTA | CHEMICAL AND MICROBIOLOGICAL METHODS FOR DRUGS QUALITY ASSESSMENT