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Presentation
Presentation
This curricular unit will cover all national and international references related to the implementation of the different stages of manufacture, registration, marketing and post-marketing of cosmetic and body hygiene products, medical devices, food supplements in particular, and foodstuffs in general.
Technical and scientific knowledge related to regulatory aspects, skills and competences will be provided and deepened in the scope of the normative standards and legal requirements applicable to the Quality Control of products and processes and to the Quality Assurance of the productive units, distributors until the placing of products in the market.
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Class from course
Class from course
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Degree | Semesters | ECTS
Degree | Semesters | ECTS
Master Degree | Semestral | 4
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Year | Nature | Language
Year | Nature | Language
1 | Mandatory | Português
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Code
Code
ULHT2629-17183
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Prerequisites and corequisites
Prerequisites and corequisites
Not applicable
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Professional Internship
Professional Internship
Não
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Syllabus
Syllabus
1. National and EU regulatory framework for cosmetics and body care products, medical devices and food supplements.
2. Quality control. Good Laboratory Practice. Flow of the raw material to finished product. Documentation. Quality tools. Validation methods. Quality control specifications. Sampling and treatment of samples for analysis. Analytical assays. Sample retaining area.
3. Packaging material. Raw material.
4. In process and finished products.
5. Records/Traceability.
6. Marketing procedures and post-market monitoring.
7. Advertising of Health Products.
8. Theoretical basis for the implementation of Quality Assurance System.
9. Good Manufacturing Practices. Supplier Qualification.
10. Development and dissemination of quality indicators. Risk Analysis and Analysis of Quality System.
11.Auto-inspections and audits of Quality/Documentation and registration. Implementation/management of a management system in an accredited testing laboratory. NP EN ISO/IEC 17025:2018.
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Objectives
Objectives
After attending this curricular unit, the student should understand the good practices applicable to all these products, from manufacturing, distribution, advertising, sale and dispensing, to their use by the final consumer and understanding the Accreditation System in Portugal as part of the structure of the Portuguese Quality System (SPQ) and its framework within the European Union and internationally.
The practical classes aim to provide the students with a more effective contact with some of the topics presented in the theoretical classes and to provide knowledge in the methods of characterization and methodologies to evaluate the quality and relate it with the safety and effectiveness of each type of products.
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Teaching methodologies and assessment
Teaching methodologies and assessment
Study Tours to PSSA production facilities
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References
References
- Cosméticos e EN ISO 22716:2007, ISO 11930:2012, ISO 11609:2010, ISO/AWI TR 18811, ISO 16128-1, ISO/CD 16128-2, ISO 22715:2006, ISO/TR 26369:2009, EN ISO 29621:2010.
- Dispositivos Médicos, DL n.º 145/2009 e ISO 13485:2016.
- Suplementos alimentares, DL n.º 136/2003, DL n.º 167/2004, DL n.º 113/2006, Regulamento n.º 1169/2011.
- Norma NP EN ISO/IEC 17025:2018.
- Ministério da Saúde, Instituto Nacional da Farmácia e do Medicamento (INFARMED) (2010). Farmacopeia Portuguesa 9.8. Lisboa: Imprensa Nacional Casa da Moeda.
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Office Hours
Office Hours
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Mobility
Mobility
No
