Ciências e Tecnologias do Fabrico II - Fful

Objectives

Introduce the students to modern manufacturing and process development tools based on designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in­process materials and processes, with the goal of ensuring final product quality. Introduce students with pharmaceutical process design (including QbD), manufacturing and life cycle management, risk analysis under a GMP environment and integrated on validated quality systems. Students are teach on how to handle large volumes of process/product data with emphasis on process analytics and real time monitoring. Pharmaceutical manufacturing paradigms like continuous manufacturing and real time release testing procedures. throrough discussions are promoted on the quality guidelines and requirements when filing new product approvals request to regulatory authorities (process focus). Skills acquired previously at MST-I are fundamental.

Syllabus

­● Analysis of batch manufacturing processes for active ingredients and medicines. ● Continuous manufacturing of medicines. ● Process analytical technologies: development of multivariate analytical methods. ● Spectroscopic methodologies for real-time process monitoring. ● Management and processing of high-throughput analytical data. ● cGMP environment: requirements and implications. ● Regulatory environment (quality guidelines). ICH quality guidelines. ● Quality risk analysis in the context of manufacturing process development. ● Pharmaceutical development using QbD principles: obtaining knowledge spaces. ● Planning and executing factorial experimental designs. ● Real-time release. ● Pharmaceutical product lifecycle management. ● Industry 4.0: tools and objectives.

Prerequisites

Any student who has been admitted to the following 2nd Cycle programs is eligible to attend this course unit: MEFARM, MIEBIOL, MEQ, MEBIOM, MEAMBI.

Cross Competence Component

This unit provides the skills necessary to be able to read, navigate and understand international GMP and Quality Systems legislation, across multiple regulatory regions, as a function of quality culture differences and its relation to patient safety, assurance in terms of therapeutic efficacy and their relation to product quality. Students learn how to interact with the regulatory agencies. Language and terminology are fine tuned as students have multiple backgrounds. Scientific data presentation skills (oral and written).

Laboratorial Component

Sessions in the pharmaceutical technology laboratory (laboratory scale). Sessions in the laboratory with analytical equipment. Sessions in the computer lab.

Programming And Computing Component

● Modde (Sartorius). ● Matlab (Mathworks). ● Excel/Power BI (Microsoft)

Ethical Principles

All members of a group are responsible for the group’s work In any assessment every student shall honestly disclose any help received and sources used. In an oral assessment, every student shall be alble to present and answer questions about the entire assignment and solution.