| Code |
13700
|
| Year |
5
|
| Semester |
S1
|
| ECTS Credits |
3
|
| Workload |
PL(10H)/T(10H)/TP(10H)
|
| Scientific area |
Ciências Farmacêuticas
|
|
Entry requirements |
Previous frequency of the UC Farmácia Galénica e Tecnologia Farmacêutica or equivalent.
|
|
Learning outcomes |
The general learning goals are: 1. To analyze the industrial drug product life cycle, with focus on the context of the paradigm “Quality by Design”; 2. To discuss, and learn how to use, the tools that support this new paradigm; 3. To develop competences in the development of new formulations applying these and previous knowledge (Galenic Pharmacy). The students should acquire the ability to: 1. Describe the evolution of the drug product and active substances quality concept, and of the ways to demonstrate and assure it; 2. To develop formulation of medicines making use of the tools of the “Quality by Design” paradigm and working as a team; 3. To discuss some aspects of scale transposition, process validation and drug product manufacture management.
|
|
Syllabus |
Global vision of formal aspects: drug product life cycle and applications for marketing authorization; International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); “Common Technical Document” (CTD) and quality modules; Good manufacturing practices; 2. Introduction of basic concepts and vocabulary [Six Sigma method, quality control – including statistical quality control, “Design of experiments (DoE), “Quality Management Systems” (ISO 9000:2005), “Knowledge management”, etc.]; 3. Evolution of the concepts related with medicine quality and ICH guidelines [“Process analytical technology” (PAT), “Quality by design”(QbD), “Quality risk management” (QRM) e “Pharmaceutical quality systems” (PQS), etc.]; 4. Pre-formulation and formulation during the preclinical phase of drug product design; 5. Scale transposition, process validation and production management;
|
|
Main Bibliography |
http://www.infarmed.pt; http://www.ich.org; http://www.fda.gov/; http://www.ema.europa.eu/ema/; ISO 9000:2005; Allen, T.T., 2006. Introduction to engineering statistics and six sigma: statistical quality control and design of experiments and systems, 1st ed. ed. Springer, London.; Lachman, L., Lieberman, H.A., Kanig, J.L., Pinto, J.E., Fernandes, 2001. Teoria e prática na indústria farmacêutica. Fundação Calouste Gulbenkian, Lisboa.; Vários artigos científicos de publicações periódicas.
|
|
Language |
Portuguese. Tutorial support is available in English.
|