FABRIZIO MERCIAI | DRUG QUALITY CONTROL

cod. 0760400044

DRUG QUALITY CONTROL

	0760400044
	DIPARTIMENTO DI FARMACIA
	EQF7
	PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY
	2024/2025

PERCORSO SHARED STUDY PATHWAY

	YEAR OF COURSE 5
	YEAR OF DIDACTIC SYSTEM 2023
	AUTUMN SEMESTER

TEACHING UNITS

	SSD	CFU	HOURS	ACTIVITY	TYPE OF ACTIVITY
1	MODULO I DI CONTROLLO DI QUALITÀ DEI MEDICINALI
	CHIM/08	3	24	LESSONS	SUPPLEMENTARY COMPULSORY SUBJECTS
2	MODULO II DI CONTROLLO DI QUALITÀ DEI MEDICINALI
	CHIM/09	3	24	LESSONS	SUPPLEMENTARY COMPULSORY SUBJECTS

PROFESSORS

	FRANCESCA SANSONE2 T Curriculum
	FABRIZIO MERCIAI1 Curriculum

	Objectives
	THE COURSE AIMS TO PROVIDE STUDENTS WITH KEY CONCEPTUAL AND OPERATIONAL KNOWLEDGE TO UNDERSTAND AND IMPLEMENT QUALITY CONTROL IN THE PHARMACEUTICAL INDUSTRY KNOWLEDGE AND UNDERSTANDING AT THE END OF THE COURSE, THE STUDENT WILL KNOW THE PHARMACOPOEIA TECHNOLOGICAL ASSAYS AND PROCEDURES (PHYSICAL-CHEMICAL, ANALYTIC, INSTRUMENTAL), AND REGULATORY STANDARDS RELATED TO QUALITY CONTROL (QC) OF PHARMACEUTICAL PRODUCTS MAKING JUDGMENTS AT THE END OF THE COURSE, THE STUDENT WILL BE ABLE TO: -DESCRIBE THE QUALITY CONTROL PROCESSES OF PHARMACEUTICAL FORMS (INDUSTRIAL MEDICINES) PRODUCED ACCORDING TO GMP -VERIFY AND TEST THE MEDICINES AT VARIOUS STAGES OF PRODUCTION, TO ENSURE EVERY PRODUCT IS OF THE HIGHEST QUALITY. -CRITICALLY ANALYZE A PRACTICAL CASE RELATED TO THE QC OF A MEDICINAL PRODUCT

THE COURSE AIMS TO PROVIDE STUDENTS WITH KEY CONCEPTUAL AND OPERATIONAL KNOWLEDGE TO UNDERSTAND AND IMPLEMENT QUALITY CONTROL IN THE PHARMACEUTICAL INDUSTRY
KNOWLEDGE AND UNDERSTANDING
AT THE END OF THE COURSE, THE STUDENT WILL KNOW THE PHARMACOPOEIA TECHNOLOGICAL ASSAYS AND PROCEDURES (PHYSICAL-CHEMICAL, ANALYTIC, INSTRUMENTAL), AND REGULATORY STANDARDS RELATED TO QUALITY CONTROL (QC) OF PHARMACEUTICAL PRODUCTS
MAKING JUDGMENTS
AT THE END OF THE COURSE, THE STUDENT WILL BE ABLE TO:
-DESCRIBE THE QUALITY CONTROL PROCESSES OF PHARMACEUTICAL FORMS (INDUSTRIAL MEDICINES) PRODUCED ACCORDING TO GMP
-VERIFY AND TEST THE MEDICINES AT VARIOUS STAGES OF PRODUCTION, TO ENSURE EVERY PRODUCT IS OF THE HIGHEST QUALITY.
-CRITICALLY ANALYZE A PRACTICAL CASE RELATED TO THE QC OF A MEDICINAL PRODUCT

	Prerequisites
	BASIC KNOWLEDGE OF ANALYTICAL AND PHARMACEUTICAL TECHNOLOGICAL CONCEPTS IS REQUIRED.

	Contents
	THE COURSE IS DIVIDED INTO 2 MODULES, NAMED: DRUG QUALITY CONTROL MODULE 1 AND DRUG QUALITY CONTROL MODULE 2 DRUG QUALITY CONTROL MODULE 1 (24H – 3CFU) INTRODUCTION TO PHARAMACEUTICAL QUALITY CONTROL: REGULATIONS AND GUIDELINES (2H – 0.25 CFU) COMPILATION AND CONTROL OF DOCUMENTATION: KEY ASPECTS IN THE PRODUCTION OF PHARMACEUTICAL PRODUCTS, QUALITY ASSURANCE SYSTEM (QAS), RESPONSIBILITY, PLANNING AND DOCUMENTATION OF ACTIVITIES (4H – 0.5 CFU) ANALYTICAL METHODS FOR DRUG QUALITY CONTROL: PRINCIPLES OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY, SUPERCRITICAL FLUID CHROMATORAPHY, TWO-DIMENSIONAL CHROMATOGRAPHY, THIN LAYER CHROMATOGRAPHY, ROLE OF MASS SPECTROMERY (6H – 0.75 CFU) QUALITY ASPECTS OF CONTROLLED DRUGS: CASE STUDY OF THERAPEUTIC CANNABIS, TITRATION OF THC AND CBD, AND STABILITY ASSESSMENT (2H – 0.25 CFU) VALIDATION OF AN ANALYTICAL METHOD: ICH Q2, PRECISION, ACCURACY, SELECTIVITY AND SENSITIVITY (2H – 0.25 CFU) A PRACTICAL LABORATORY EXPERIENCE WILL BE PERFORMED (6H - 0.75 CFU) DRUG QUALITY CONTROL MODULE 2 (24H – 3CFU) QUALITY CONTROL - MODULE 2 DURATION: 24 HOURS - 3 CFU 1.TECHNICAL STANDARDS, SOURCES OF LEGITIMATION, AND REFERENCE PHARMACOPOEIAS (2 HOURS - LECTURE) •INTRODUCTION TO TECHNICAL STANDARDS AND SOURCES OF LEGITIMATION IN THE PHARMACEUTICAL SECTOR. •OVERVIEW OF MAJOR REFERENCE PHARMACOPOEIAS. 2.MEDICINES AND PHARMACEUTICAL FORMS (2 HOURS - LECTURE) •CLASSIFICATION OF MEDICINES AND PHARMACEUTICAL FORMS. •IN-DEPTH STUDY OF DIFFERENT TYPES OF PHARMACEUTICAL FORMS. 3.TECHNOLOGICAL REQUIREMENTS OF PHARMACEUTICAL FORMS AS PER PHARMACOPOEIA A. MEDICINES FOR ORAL ADMINISTRATION (4 HOURS - LECTURE) •IN-DEPTH STUDY OF TECHNOLOGICAL REQUIREMENTS OF PHARMACEUTICAL FORMS FOR ORAL ADMINISTRATION, INCLUDING MODIFIED-RELEASE MEDICINES. B. MEDICINES FOR DERMATOLOGICAL ADMINISTRATION (2 HOURS - LECTURE) •ANALYSIS OF DERMATOLOGICAL SUSPENSIONS, GELS, AND EMULSIONS. C. MEDICINES FOR INHALATION ADMINISTRATION (2 HOURS - LECTURE) •STUDY OF DRY POWDERS FOR INHALATION AND THEIR TECHNOLOGICAL REQUIREMENTS. 4.TESTS REQUIRED BY PHARMACOPOEIA FOR TECHNOLOGICAL SPECIFICATIONS CONTROL (4 HOURS - LECTURE) •DESCRIPTION AND PRACTICE OF TESTS REQUIRED BY PHARMACOPOEIA TO VERIFY TECHNOLOGICAL SPECIFICATIONS OF MEDICINES. 5.TESTS REQUIRED BY TECHNICAL STANDARDS (ICH, ISO) FOR MINIMUM AND VOLUNTARY QUALITY REQUIREMENTS CONTROL (2 HOURS - LECTURE) •IN-DEPTH STUDY OF TESTS FOR QUALITY CONTROL REQUIRED BY INTERNATIONAL REGULATIONS (ICH, ISO) TO ENSURE THE QUALITY OF MEDICINES. 6.LABORATORY PRACTICE IN SMALL GROUPS •APPLICATION OF TECHNOLOGICAL PROCEDURES IN MEDICINE CONTROL THROUGH TESTS AND CASE STUDIES. •DURATION: 6 HOURS - LABORATORY.

Contents

THE COURSE IS DIVIDED INTO 2 MODULES, NAMED: DRUG QUALITY CONTROL MODULE 1 AND DRUG QUALITY CONTROL MODULE 2
DRUG QUALITY CONTROL MODULE 1 (24H – 3CFU)
INTRODUCTION TO PHARAMACEUTICAL QUALITY CONTROL: REGULATIONS AND GUIDELINES (2H – 0.25 CFU)
COMPILATION AND CONTROL OF DOCUMENTATION: KEY ASPECTS IN THE PRODUCTION OF PHARMACEUTICAL PRODUCTS, QUALITY ASSURANCE SYSTEM (QAS), RESPONSIBILITY, PLANNING AND DOCUMENTATION OF ACTIVITIES (4H – 0.5 CFU)
ANALYTICAL METHODS FOR DRUG QUALITY CONTROL: PRINCIPLES OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY, SUPERCRITICAL FLUID CHROMATORAPHY, TWO-DIMENSIONAL CHROMATOGRAPHY, THIN LAYER CHROMATOGRAPHY, ROLE OF MASS SPECTROMERY (6H – 0.75 CFU)
QUALITY ASPECTS OF CONTROLLED DRUGS: CASE STUDY OF THERAPEUTIC CANNABIS, TITRATION OF THC AND CBD, AND STABILITY ASSESSMENT (2H – 0.25 CFU)
VALIDATION OF AN ANALYTICAL METHOD: ICH Q2, PRECISION, ACCURACY, SELECTIVITY AND SENSITIVITY (2H – 0.25 CFU)
A PRACTICAL LABORATORY EXPERIENCE WILL BE PERFORMED (6H - 0.75 CFU)
DRUG QUALITY CONTROL MODULE 2 (24H – 3CFU)
QUALITY CONTROL - MODULE 2 DURATION: 24 HOURS - 3 CFU
1.TECHNICAL STANDARDS, SOURCES OF LEGITIMATION, AND REFERENCE PHARMACOPOEIAS (2 HOURS - LECTURE)
•INTRODUCTION TO TECHNICAL STANDARDS AND SOURCES OF LEGITIMATION IN THE PHARMACEUTICAL SECTOR.
•OVERVIEW OF MAJOR REFERENCE PHARMACOPOEIAS.
2.MEDICINES AND PHARMACEUTICAL FORMS (2 HOURS - LECTURE)
•CLASSIFICATION OF MEDICINES AND PHARMACEUTICAL FORMS.
•IN-DEPTH STUDY OF DIFFERENT TYPES OF PHARMACEUTICAL FORMS.
3.TECHNOLOGICAL REQUIREMENTS OF PHARMACEUTICAL FORMS AS PER PHARMACOPOEIA A. MEDICINES FOR ORAL ADMINISTRATION (4 HOURS - LECTURE)
•IN-DEPTH STUDY OF TECHNOLOGICAL REQUIREMENTS OF PHARMACEUTICAL FORMS FOR ORAL ADMINISTRATION, INCLUDING MODIFIED-RELEASE MEDICINES. B. MEDICINES FOR DERMATOLOGICAL ADMINISTRATION (2 HOURS - LECTURE)
•ANALYSIS OF DERMATOLOGICAL SUSPENSIONS, GELS, AND EMULSIONS. C. MEDICINES FOR INHALATION ADMINISTRATION (2 HOURS - LECTURE)
•STUDY OF DRY POWDERS FOR INHALATION AND THEIR TECHNOLOGICAL REQUIREMENTS.
4.TESTS REQUIRED BY PHARMACOPOEIA FOR TECHNOLOGICAL SPECIFICATIONS CONTROL (4 HOURS - LECTURE)
•DESCRIPTION AND PRACTICE OF TESTS REQUIRED BY PHARMACOPOEIA TO VERIFY TECHNOLOGICAL SPECIFICATIONS OF MEDICINES.
5.TESTS REQUIRED BY TECHNICAL STANDARDS (ICH, ISO) FOR MINIMUM AND VOLUNTARY QUALITY REQUIREMENTS CONTROL (2 HOURS - LECTURE)
•IN-DEPTH STUDY OF TESTS FOR QUALITY CONTROL REQUIRED BY INTERNATIONAL REGULATIONS (ICH, ISO) TO ENSURE THE QUALITY OF MEDICINES.
6.LABORATORY PRACTICE IN SMALL GROUPS
•APPLICATION OF TECHNOLOGICAL PROCEDURES IN MEDICINE CONTROL THROUGH TESTS AND CASE STUDIES.
•DURATION: 6 HOURS - LABORATORY.

	Teaching Methods
	THE COURSE (6 CFU) COMPRISES 48 HOURS OF LESSONS, DIVIDED IN TWO MODULES. BOTH MODULES (1 AND 2) CONSIST OF 18 HOURS OF LESSONS (18 HOURS MODULE 1 + 18 HOURS MODULE 2) AND 6 HOURS OF PRACTICAL ACTIVITIES IN SMALL GROUPS IN LABORATORY (6 HOURS MODULE 1 + 6 HOURS MODULE 2).

	Verification of learning
	THE ASSESSMENT OF LEARNING IS CONDUCTED THROUGH BOTH A WRITTEN EXAMINATION AND AN ORAL EXAMINATION. THE WRITTEN EXAMINATION (1 HOUR) COMPRISES 15 QUESTIONS OFFERING 4 POTENTIAL RESPONSES, OF WHICH ONLY ONE IS DEEMED CORRECT, AND 3 OPEN-ENDED INQUIRIES. THESE QUESTIONS COMPREHENSIVELY COVER THE ENTIRETY OF THE COURSE. EACH CORRECT RESPONSE TO THE MULTIPLE-CHOICE QUERIES ASSIGNS A SCORE OF 1 POINT FOR 12 QUESTIONS AND 2 POINTS FOR THE REMAINING 3 QUESTIONS. AN INCORRECT RESPONSE DOES NOT ASSIGN PENALTIES. A MAXIMUM OF 18 POINTS CAN BE OBTAINED THROUGH THIS SECTION. THE CORRECT ANSWER TO EACH OPEN-ENDED QUESTION IS AWARDED A SCORE OF 4 POINTS. ASSESSMENTS ARE GRADED ON A SCALE OF THIRTY. THE SUCCESSFUL COMPLETION OF THE WRITTEN EXAMINATION IS PREREQUISITE TO UNDERTAKING THE ORAL EXAMINATION. THE ORAL EXAMINATION WILL BE BASED ON A REVIEW AND DISCUSSION OF THE WRITTEN EXAMINATION, FOLLOWED BY A DISCUSSION ABOUT THE ARGUMENTS EXPLAINED DURING THE COURSE. THE STUDENT'S ABILITY TO CRITICALLY ANALYZE THE TOPICS OF THE COURSE, HIS COMMUNICATION SKILLS AND SCIENTIFIC LANGUAGE WILL BE CONSIDERED FOR THE FINAL ASSESSMENT. THE FINAL GRADE IS DETERMINED BY THE WEIGHTED AVERAGE OF THE TWO EXAMINATION COMPONENTS (WRITTEN AND ORAL).

Verification of learning

THE ASSESSMENT OF LEARNING IS CONDUCTED THROUGH BOTH A WRITTEN EXAMINATION AND AN ORAL EXAMINATION. THE WRITTEN EXAMINATION (1 HOUR) COMPRISES 15 QUESTIONS OFFERING 4 POTENTIAL RESPONSES, OF WHICH ONLY ONE IS DEEMED CORRECT, AND 3 OPEN-ENDED INQUIRIES. THESE QUESTIONS COMPREHENSIVELY COVER THE ENTIRETY OF THE COURSE. EACH CORRECT RESPONSE TO THE MULTIPLE-CHOICE QUERIES ASSIGNS A SCORE OF 1 POINT FOR 12 QUESTIONS AND 2 POINTS FOR THE REMAINING 3 QUESTIONS. AN INCORRECT RESPONSE DOES NOT ASSIGN PENALTIES. A MAXIMUM OF 18 POINTS CAN BE OBTAINED THROUGH THIS SECTION. THE CORRECT ANSWER TO EACH OPEN-ENDED QUESTION IS AWARDED A SCORE OF 4 POINTS. ASSESSMENTS ARE GRADED ON A SCALE OF THIRTY. THE SUCCESSFUL COMPLETION OF THE WRITTEN EXAMINATION IS PREREQUISITE TO UNDERTAKING THE ORAL EXAMINATION. THE ORAL EXAMINATION WILL BE BASED ON A REVIEW AND DISCUSSION OF THE WRITTEN EXAMINATION, FOLLOWED BY A DISCUSSION ABOUT THE ARGUMENTS EXPLAINED DURING THE COURSE. THE STUDENT'S ABILITY TO CRITICALLY ANALYZE THE TOPICS OF THE COURSE, HIS COMMUNICATION SKILLS AND SCIENTIFIC LANGUAGE WILL BE CONSIDERED FOR THE FINAL ASSESSMENT. THE FINAL GRADE IS DETERMINED BY THE WEIGHTED AVERAGE OF THE TWO EXAMINATION COMPONENTS (WRITTEN AND ORAL).

	Texts
	SKOOG, WEST, HOLLER, CROUCH, FONDAMENTI DI CHIMICA ANALITICA, EDISES FARMACOPEA UFFICIALE ITALIANA (FUI), EUROPEAN PHARMACOPOEIA (EP), UNITED STATES PHARMACOPOEIA (USP): EDIZIONI CORRENTI. AULTON M.E., KEVIN M.G.T., TECNOLOGIE FARMACEUTICA. EDRA, 2015. HOWARD C. ANSEL, SHELLY J STOCKTON, PRINCIPI DI CALCOLO FARMACEUTICO. A CURA DI: G. COLOMBO ET AL. EDRA, 2017.

	More Information
	LANGUAGE OF TEACHING: ITALIAN; LOCATION OF THE LECTURES: DEPARTMENT OF PHARMACY. FOR FURTHER INFORMATION CONTACT THE TEACHERS: FSANSONE@UNISA.IT, FMERCIAI@UNISA.IT

Lessons Timetable

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FABRIZIO MERCIAI | DRUG QUALITY CONTROL