- Oggetto:
- Oggetto:
Good manufacturing practice in a hospital laboratory
- Oggetto:
Good manufacturing practice in a hospital laboratory
- Oggetto:
Academic year 2021/2022
- Course ID
- SVB0213
- Teacher
- Katia Mareschi
- Degree course
- Cellular and Molecular Biology
- Year
- 2nd year
- Teaching period
- To be defined
- Type
- Elective
- Credits/Recognition
- 2
- Course disciplinary sector (SSD)
- MED/46 - scienze tecniche di medicina e di laboratorio
- Delivery
- Blended
- Language
- English
- Attendance
- Obligatory
- Type of examination
- Written and interview
- Prerequisites
- Laboratory Quality Management System
Quality system Key concepts and principles
Certification and Accreditation
ISO 9000 standards - Propedeutic for
- Quality management in a clinical laboratory and GMP guidelines
- Oggetto:
Sommario del corso
- Oggetto:
Course objectives
This teaching contributes to the learning objectives useful to access a Good Manufacturing Practice (GMP) laboratory where cellular products are manufactured for clinical use. In particular teaching objectives are:
- Introduction to Laboratory Quality management
- Introduction to GMP guidelines
- Regulation for Advanced Therapy Medicinal Products (ATMPs)
- Quality management in an AIFA accredited laboratory for ATMP products
- Oggetto:
Results of learning outcomes
At the end of the course, the students will acquire new knowledge on:
- General aspects on Quality management in a hospital laboratory
- GMP guidelines
- Regulations for clinical use of Advanced Therapy Medicinal Products (ATMPs)
- Cell factory description: what is it? How do you work and which procedures do you need to use inside?
- Risk management in a ATMP manufacturing process: from the raw materials to the patient, with a practical example
- Oggetto:
Course delivery
Teaching includes 2 CFU and will consist of 6 theoretical lessons (2 hours for each lesson) + 2 practical lessons (in small groups) at the Stem Cell Transplantation and Cellular Therapy Laboratory, Department of Public Health and Paediatrics, University of Turin, Italy; Regina Margherita Children's Hospital, Piazza Polonia 94.
The lectures are held in the classroom and contemporarly available live streaming on webex.
In case of impossibility to develop the course in this way, distance teaching will be activated on the webex platform.
All teaching material will be available on campusnet platform or Moodle platform..
- Oggetto:
Learning assessment methods
Learning will be verified by a written test consisting of a questionnaire (open questions, multiple choice quizzes, true/false, short answers, open-ended questions; interpretation of experimental data and resolution of exercises) dealing with all the teaching program developed during the course. Time: 60'
The final learning assessment will be held in presence, in written form with oral integration.
Grading is out of 30, with "cum laude" counted as 33/30.
The ability to analyse a risk management in a specific process and interpret correctly the regulations will be evaluated by a Moodle-based test, which is composed of practical exercises. Students are required to answer questions (multiple choice, short answer, short essay). Grading is out of 30, with "cum laude" counted as 33/30.
The final grade is the arithmetic mean of the two single grades. The "cum laude" is assigned when one of the single grades is "cum laude" (33/30) and the general average is above 30.
Students belonging to specific categories will be allowed to participate in online written exams (webex platform), followed by a mandatory oral exam.
Before performing the test, Students are required to read the Ethical Code: https://www.unito.it/sites/default/files/allegati/01-08-2014/cod_etico_comunita_universitaria.pdf
An English translation is provided here: Code of Ethical Conduct
- Oggetto:
Support activities
Selected readings and current regulations will be provided on the campusnet or moodle platform;
external in-depth videos and teaching material on specific topics will be uploaded to the Moodle platform
- Oggetto:
Program
Unit 1- Introduction to the quality management system in a hospital laboratory
- The quality system essentials
- Approaches to Quality Management
- Accreditation and certification
Unit 2 -Good manufacturing practice (GMP)
- Quality system, key concepts and principles
- Basic requirements for medicinal products
- Pharmaceutical Quality System
- Personnel
- Premise and Equipment
- Documentation
- Quality control
- Outsourced activity
- Complaint and product recall
- Self inspections
Unit 3. Regulations for clinical use of Advanced Therapy Medicinal Products (ATMPs)
- Good laboratory practice (GLP)
- Good clinical practice (GCP)
- Good manufacturing practice (GMP)
- Clinical trial phases
- Authorization Institutions (AIFA/ISS and EMA)
Unit 4. Implementation of a GMP system
- Personnel, training, documents
- Production
- Quality control
- Risk analysis
- Qualification and validation
- Raw materials
- GMP related documents
- Site Master File
- Quality Risk Management
- Validation master plan
Unit 5. ATMP production: from the raw materials to the patient
- Example of ATMP production: from raw materials to clinical application
- Media Fill
- Process Validation
- Stability program
- Transport validation
- Batch release
Unit 6. Practical lessons
Practical exercises evaluating different processes in Cell Factory and visit to the GMP quality control laboratory and cell therapy laboratory (work group)
Suggested readings and bibliography
- Oggetto:
All teaching material (slides, selected papers, e-books and websites) are fully available on Campusnet or Moodle platform
- Oggetto:
