Cellular and Molecular Biology

Good manufacturing practice in a hospital laboratory

Good manufacturing practice in a hospital laboratory

Academic year 2023/2024

Sommario del corso

• Course objectives
• Results of learning outcomes
• Program
• Course delivery
• Learning assessment methods
• Support activities
• Suggested readings and bibliography
• Teaching tools
• Course card

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

Results of learning outcomes

Knowledge and understanding:

At the end of the course, the students will acquire new knowledge and understanding 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

Applying knowledge and understanding:

At the end of the course, students are expected to be able:

• To know the regulations for clinical use of Advanced Therapy Medicinal Products (ATMPs)
• To describe a cell factory and how is possible to work inside
• To perform a risk analysis about a cell process

Making judgements:

At the end of the course the students will be able to integrate data from the European Regulations with the acquired knowledges, to manage a risk analysis in a cell manufacturing process and resolve questions about the ATMP production.

Communication skills:

At the end of the course students should Communicate knowledge acquired at the dissemination or specialist level.

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)

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.

All lectures will be delivered in presence, subject to updates on the measures adopted by UniTo which can be found on the University portal under "Provisions for those who study and work at UniTo" (see https://en.unito.it/studying-unito)

All teaching material will be available on Moodle platform.

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 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). 

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.

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

Support activities

Selected readings and current regulations will be provided on moodle platform;

 external in-depth videos and teaching material on specific topics will be uploaded to the Moodle platform

All teaching material (slides, selected papers, e-books and websites) are fully available on  Moodle platform

• Teaching material
• Exams and finals
• Class schedule
• Go to Moodle
• Register for the course
• Enrolled students
• Invia email agli studenti registrati
• Export table