Base Knowledge
Not applied
Teaching Methodologies
The curricular unit is taught in theoretical classes and theoretical-practical classes.
The teaching methodology comprises theoretical exposition, participation of invited specialists, analysis of studies,
individual research and development and presentation of a work on a theme to be defined within the Curricular Unit
syllabus.
The evaluation includes the development and presentation of a group work with oral presentation (50%) and written
evaluation (50%).
Learning Results
The main objective of this curricular unit is to transmit to students a wide range of knowledge in the field of Quality,
namely those related to Quality Control. It is intended that students learn and apply techniques and methodologies
for statistical quality control that allows monitoring and improving product processes. The intervention domains of
the course give students the opportunity to learn how to solve problems in a structured way through the
application of quality tools, analysis of data obtained by experimentation that will serve to optimize the
performance of processes and products, or even of compliance measure and monitor the stability of processes and
their ability or ability to meet customer requirements.
Program
1.Importance of Quality Control and Quality Assurance in Pharmacy
2.Quality Management System and Standardization in Portugal; NP EN ISO 9001: 2015.
3.Authenticity, Standardization and Product Quality Certification
4. Validation of analytical methods. The importance of the ICH guidelines. Parameters for evaluating the
performance of the method;
5. Quality control of medicines and medicinal plants
6. Quality control of dermocosmetics
7. Chemical / Toxicological Control
8. Biological Control
9. Sensory control
Grading Methods
Continuous evaluation:
Development and presentation of a group work with oral presentation (50%) and written assessment (50%).
Exams in accordance with the academic regulation
Internship(s)
NAO
Bibliography
Primary bibliography:
-Skoog Douglas A.; Principles of instrumental analysis. ISBN: 0-03-001229-5;
-Prista Luís Vasco Nogueira; Dermofarmácia e cosmética, 1992
-Prista L. Nogueira; Tecnologia farmacêutica. ISBN: 978-972-31-0975-7
Secondary bibliography:
-NP EN ISO 9001:2015. Sistemas de gestão da qualidade – Requisitos.
– NP EN ISO 9000:2005. Sistema de gestão da qualidade – Fundamentos de vocabulário.
ISO/IEC 17021-1:2015. Conformity assessment – Requirements for bodies providing audit certification of managementsystems – Part 1: Requirements
-Rouessac Francis; Chemical analysis: modern instrumental methods and techniques. ISBN: 0-471-97261-4
-Harris Daniel C.; Quantitative chemical analysis. ISBN: 0-7167-4464-3
-Comissão da Farmacopeia Portuguesa; Farmacopeia portuguesa VIII. ISBN: 972-8425-67-8