The course offers the student a broad view on the activities of Good Manufacturing Practices (GMP) which together represent a concept of concepts that identify important aspects in the production of a drug. The application of the GMP Guidelines is mandatory by law in pharmaceutical manufacturing. A pharmaceutical workshop must comply with the GMP standards, compliance which must be confirmed through inspection visits by the Competent Authority, which for Italy is the Italian Medicines Agency (AIFA). The course discusses the legislative aspects that regulate the processing and organization of drug production facilities.
Know the legislation and indicate the operational tools; Understand current EU and FDA requirements for drug production and control; Design, implement and maintain a compliant system; Identify the roles and responsibilities of key figures as required by regulations; Management and evaluation of its Quality System.
The training includes a broad knowledge of the legislation and of the operational tools for the production and control of drugs; design, implement and maintain a compliant system for pharmaceutical processing; Identify the roles and responsibilities of key figures in production processes as required by regulations; management and evaluation of its Quality System.
The learning outcomes will be verified on an ongoing basis with extensive interactive discussions on the topics covered and through a final evaluation exam.
Basic biology knowledge.
The final assessment of learning concerns an interview to verify the acquired knowledges.
Any Student with documented Specific Learning Disorders (SLD), or with any special needs, should contact the Lecturer(s) and to the dedicated SLD Representative in the Department before class begins, in order to liaise and arrange the specific teaching methods so that the learning aims and outcomes may be met.
Notes on Biological and Biotechnological Medicines
Advanced therapies: medicinal products
Legislation governing the production of medicinal products in advanced therapies
Definition and characteristics of Good Standard Practices: GLP, GMP, GCP
Regulatory agencies: AIFA, EMA, FDA
Regulatory inspections
Assay centers and clinical study processing
Operation of GLP: Management of laboratories; Study Director; Quality Control Unit, Guidelines
Behavioral rules in Cell Factory
Cell Factory facilities
Processing methods in the Cell Factory: classification of areas
Staff training In GMP
Sanitization of GMP premises
MADDALENA MASTROGIACOMO (President)
GILBERTO FILACI
CHIARA GENTILI
I semester.
Written or oral test.
Multiple-choice test in the written version.
Questions and discussion of the Argometi treated in the oral version.
