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Good manufacturing practice: the hospital laboratory
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Good manufacturing practice: the hospital laboratory
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Academic year 2019/2020
- Course ID
- SVB0191
- Teacher
- Katia Mareschi
- Degree course
- Cellular and Molecular Biology
- Year
- 2nd year
- Type
- Elective
- Credits/Recognition
- 1
- 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
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Sommario del corso
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Course objectives
- Introduction to Good Manufacturing Practice (GMP) guidelines
- Regulation for research and Advanced Therapy Medicinal Products (ATMPs)
- Quality management in an AIFA accredidated laboratory for ATMP products
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Results of learning outcomes
At the end of the course the students will acquire new acknowledgements on:
- GMP guidelines
- Rregulations for clinical use of Advanced Therapy Medicinal Products (ATMPs)
- ATMP production: from the raw materials to the patient with a practice example
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Course delivery
The course GOOD MANUFACTURING PRACTICE: THE HOSPITAL LABORATORY will consist of 4 theory lessons (2 hours for each lesson) + 2 practice lessons (in small groups) at the Stem Cell 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.
In case of impossibility to develop the course in this way, distance teaching will be activated on the webex platform
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Learning assessment methods
Learning will be verified by a written test consisiting of a series of questions dealing with all the teaching program developed during the course.
Max punctuation will be 30/30, every question having the same weight. Particularly relevant executions will be marked cum laude.
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Support activities
2 practice lessons (in small groups) will be will be held at the Stem Cell 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.
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Program
Unit 1- Introduction to Good manufacturing practice (GMP)
- Quality system Key concepts and principles
- Certification and Accreditation
- Basic requirements for medicinal products
- Pharmaceutical Quality System
- Personnel
- Premise and Equipment
- Documentation
- Quality control
- Outsourced activity
- Complaint and product recall
- Self inspections
Unit 2. 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 3. 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 4. ATMP production: from the raw materials to the patient
- Example di ATMP production: from raw materials to clinical application
- Mediafill
- Production Process Validation
- Stability program
- Transport validation
- Certificate release
Visit to the GMP quality control laboratory and cell therapy laboratory (group work)
Suggested readings and bibliography
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In attachement you can find useful teaching material about quality management and GMP guidelines in addition to the course slides
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