Teaching Methodologies
Theoretical classes using the expository and interrogative method.
Guidance of students’ autonomous study by consulting the recommended bibliography.
Analysis and discussion of scientific articles.
Distributed assessment with final exam + Presentation of a written work
The final classification is calculated taking into account the two components: Theoretical Exam (ET) and Written Work (TE). OET (65%) consists of a written exam on the subjects presented in the theoretical classes. The TE (35%) consists of the presentation of an individual work based on selected scientific articles.
The final calculation has the following weighting: (ET x 0.65) + (TE x 0.35)
Learning Results
Students are expected to:
O1) Know the concepts and essential aspects of the industrial production of medicines.,
O2) Know the requirements inherent to good drug manufacturing practices.
O3) Acquire basic knowledge of industrial production methods of conventional pharmaceutical forms.
O4) Acquire knowledge about the functioning of a pharmaceutical industrial unit, as well as about all regulatory procedures.
O5) Understand the different requirements of industrial production of solid, liquid and semi-solid dosage forms.;
O6) Have the ability to work autonomously with information research using pharmaceutical technology information sources.
Program
Industrial production: pharmaceutical specialties, basic characteristics of industrial drug production.
Legislation that regulates the industrial production of medicines in Portugal.
Notions of good manufacturing practices.
Requirements of industrial units for the industrial production of medicine, as well as fundamental operational procedures to guarantee the quality of pharmaceutical manufacturing activities.
Scale transfer for industrial facilities and validation of manufacturing processes.
Pharmaceutical raw materials and packaging materials
Basics of drug stability.
Industrial production of solid dosage forms.
Industrial production of liquid dosage forms.
Industrial production of semi-solid dosage forms.
Internship(s)
NAO
Bibliography
1. http://www.infarmed.pt (consulta de documentos relevantes).
2. http://www.ich.org (consulta de documentos relevantes).
3. http://www.ema.europa.eu/ema/ (consulta de documentos relevantes).
4. Lachman, L., Lieberman, H.A., Kanig, J.L., Pinto, J.E., Fernandes, 2001. Teoria e prática na indústria farmacêutica.Fundação Calouste Gulbenkian, Lisboa.
5. Rules and Guidance for Pharmaceutical Manufacturers and Distributors, 2014 (The Orange Guide) by Medicines andHealthcare Products Regulatory Agency, pharmaceutical press, 2014. 6. Thomas M. Jacobsen, Albert I. Wertheimer,Modern Pharmaceutical Industry, Jone and Bartlett Publishers, 2009.
7. Aulton M.E. [et al.], 2005, Delineamento de Formas Farmacêuticas, Segunda edição, Artmed Editora, Porto Alegre.