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Pharmaceutical Industries

Code:

MEBQ015

Sigla:

IF

Áreas Científicas
Classificação	Área Científica
OFICIAL	Biotecnologia

Ocorrência: 2023/2024 - 1S

Ativa?	Yes
Unidade Responsável:	Departamento de Engenharia Química e Biológica
Curso/CE Responsável:	Master in Biological and Chemical Engineering

Ciclos de Estudo/Cursos

Sigla	Nº de Estudantes	Plano de Estudos	Anos Curriculares	Créditos UCN	Créditos ECTS	Horas de Contacto	Horas Totais
MEBQ	12	Study Plan	2	-	3	30	81

Língua de trabalho

Portuguese

Objetivos

It is intended that students acquire knowledge and understanding of the fundamental concepts and main operations, techniques and procedures used in the pharmaceutical industry, from the procedures for drug product marketing authorization, drug product formulation and production to its distribution and marketing. The student will analyse the organization and quality management in the pharmaceutical industry throughout the lifecycle of the drug product and develop skills related to industrial production and quality management of active substances and drug product.

Resultados de aprendizagem e competências

Not applicable.

Modo de trabalho

Presencial

Programa

1. Regulatory affairs: Authorization Procedures for drug product marketing. ICH’s (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use); CTD (Common Technical Document) submission and quality modules; good manufacturing practices (GMP’s).
2. Pharmaceutical formulation.
3. Analytical methods and quality control: most used analytical methods, establishment of specifications, analytical methods development and validation.
4. Production: active principle (drug substance) and finishing product (drug product), description of the manufacturing process and process validation, production equipment, storage and distribution, master batch record, in process control, excipients control, finishing product control, container closure systems and stability and product expiration date.

Bibliografia Obrigatória

Infarmed; http://www.infarmed.pt
ICH; http://www.ich.org
FDA; http://www.fda.gov/
EMA; http://www.ema.europa.eu/ema/

Bibliografia Complementar

Lachman, L., Lieberman, H.A., Kanig, J.L.; Teoria e prática na indústria farmacêutica, Fundação Calouste Gulbenkian, Lisboa, 2001
Medicines and Healthcare Products Regulatory Agency; Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide), Pharmaceutical Press, 2014
Thomas M. Jacobsen, Albert I. Wertheimer; Modern Pharmaceutical Industry, Jone and Bartlett Publishers, 2009
Elisabeth Goodman, John Riddell; Knowledge Management in the Pharmaceutical Industry, Gower Publisher, 2014

Métodos de ensino e atividades de aprendizagem

This curricular unit comprises a theoretical/practical component. The theoretical component is taught via computer readable presentations of PowerPoint. The practical component includes classes in analysis of case studies and mini-projects.
The evaluation of the curricular unit may be continuous, by performing two tests during the semester (1st test 50%, 2nd test 50%). The evaluation may also be composed entirely of the final exam in 1st or 2nd season (100%).

Tipo de avaliação

Distributed evaluation with final exam

Componentes de Avaliação

Designation	Peso (%)
Teste	100,00
Total:	100,00

Componentes de Ocupação

Designation	Tempo (Horas)
Estudo autónomo	51,00
Frequência das aulas	30,00
Total:	81,00

Obtenção de frequência

Not applicable

Fórmula de cálculo da classificação final

Evaluation on lective period:
0.5(grade 1st test)+ 0.5(grade 2nd test)

Without minimal grade in each test. Weighted average of test equal or above 9.5 values.

Exam (all seasons): 100% exam. Minimal grade in exam: 9.5 values.