OVERVIEW

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.

AIMS AND CONTENT

LEARNING OUTCOMES

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.

AIMS AND LEARNING OUTCOMES

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.

PREREQUISITES

Basic biology knowledge.

TEACHING METHODS

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.

SYLLABUS/CONTENT

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

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

I semester.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

Written or oral test.

ASSESSMENT METHODS

Multiple-choice test in the written version.

Questions and discussion of the Argometi treated in the oral version.