References and Quality Assessment

Recommended Prerequisites

Basic notions on Quality Control, General Chemistry.

Teaching Methods

The lectures are intended to explain theoretical concepts, conveniently illustrated with relevant application examples, using visual media. The lectures are taught in an informal way, asking for active student participation. The practical classes concern practical cases and are built on problem-based learning.

Learning Outcomes

1 - Knowledge and justification of the importance of quality control in the various phases of the cycles of medicines and dietary supplements.

2- Development of concepts related to the strategy and implementation of analytical validation, application of Good Laboratory Practice, different phases of study, analytical methods, assessment of critical points, preparation of validation protocols and reports, and revalidation, in accordance with recent EU guidelines.

3 - Providing students with a comprehensive view of analytical methodologies for identification and quantification of active principles and contaminants in medicines and food supplements, as well as the alteration processes that may occur during production, transformation, packaging, transport and storage.

4 - Interpretation of quality guidelines for medicines and food supplements. 

Work Placement(s)

No

Syllabus

I-Circuits of medicines and food supplements

- Technical-Scientific Assessment

- Quality control: when and why?

- Analytical validation of methods: fundamental concepts and terminology.

II - Guiding standards and legislation

III - Quality variation assurance and control

IV - Control of raw materials, packaging materials, labeling

V - Control of the finished product.

Assessment Methods

Assessment
Exam: 100.0%

Bibliography

European Pharmacopoeia, 10th edition (2019). European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg.

Decreto-lei 118/2015, de 23 de Junho.

Berginc K, Kreft S (2015). Dietary Supplements: Safety, Efficacy and Quality. Woodhead Publishing, Waltham, MA. ISBN: 978-1-78242-076-7.

ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology. EMA, 1995.

Guideline on Bioanalytical method validation. EMA, 2011.

Harris DC, Lucy CA (2010). Quantitative Chemical Analysis. 10th Ed., W. H. Freeman, New York. ISBN: 978-1-31916-430-0.

Skoog DA, Holler FJ, Crouch SR (2017). Principles of Instrumental Analysis. 7th Ed., Cengage Learning, .ISBN: ‎ 978-1-30557-721-3.