First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
CHEMISTRY AND PHARMACEUTICAL TECHNIQUES
Course unit
PRODUCTION AND CONTROL OF PHARMACEUTICAL AND COSMETIC FORMULATIONS
MEP3052617, A.A. 2019/20

Information concerning the students who enrolled in A.Y. 2015/16

Information on the course unit
Degree course 5 years single cycle degree in
CHEMISTRY AND PHARMACEUTICAL TECHNIQUES
FA1733, Degree course structure A.Y. 2009/10, A.Y. 2019/20
N0
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Number of ECTS credits allocated 6.0
Type of assessment Mark
Course unit English denomination PRODUCTION AND CONTROL OF PHARMACEUTICAL AND COSMETIC FORMULATIONS
Department of reference Department of Pharmaceutical and Pharmacological Sciences
Mandatory attendance
Language of instruction Italian
Branch PADOVA
Single Course unit The Course unit CANNOT be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit

Lecturers
Teacher in charge MARGHERITA MORPURGO CHIM/09

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses CHIM/09 Applied Technological Pharmaceutics 6.0

Course unit organization
Period First semester
Year 5th Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Laboratory 1.0 15 10.0 No turn
Lecture 5.0 40 85.0 No turn

Calendar
Start of activities 30/09/2019
End of activities 18/01/2020
Show course schedule 2019/20 Reg.2009 course timetable

Examination board
Examination board not defined

Syllabus
Prerequisites: Students must have followed classes and teaching labs of Pharmaceutical Technology, Galenic formulation, nalysis of medicinal compounds 1&2 and analytical chemistry
Target skills and knowledge: The course, divided into theoretical lessons and experimental exercises, will bring to the students basic konwledge on the GMP procedures for the preparation and control of drug and cosmetic products according to industrial quality standards.
Examination methods: written test with a blend of multiple choice and open questions
Assessment criteria: the final score will take into consideration the rsults of the written test, and the quality of activities carried out during the training and the documents generated thereof.
Course unit contents: - functions and responsibilities in the pharmaceutical industry
- good manufacturing practices according to EMA rules:
- the pharmaceutical quality system;
- staff requirements;
- the requirements of the work environment;
- the management of machinery and equipment;
- roles and functions in pharmaceutical production;
- roles and functions in quality control;
- documentation production and management;
- the qualification and validation procedures
- pharmaceutical stability

In the 15 hours of the laboratory, the students will deal with the preparation and control of a batch of medicinal product, will set the preparation and control procedures and draw up the batch record.
Planned learning activities and teaching methods: 40 hours of lectures and 15 hours of laboratory;
testimonials are provided by staff of pharmaceutical companies;
Additional notes about suggested reading: The main reference for the course are the slides provided by the teacher.
Textbooks (and optional supplementary readings)