Medicinal Product Quality Control

Recommended Prerequisites

Pharmaceutical Forms. Quality control notions.

Teaching Methods

Plenary lectures. Laboratory training to control medicinal dosage forms.

Learning Outcomes

Understanding and justify the relevance of quality control at different stages of drugs life cycle.

Skill to justify the relationship between Quality assurance and Control of quality.

Interpretation of Guidelines.

Differentiation between pharmotechnical analysis according to the type of dosage forms.

Skill to carry controls of medicinal dosage forms.

Work Placement(s)

No

Syllabus

Plenary lectures:

Medicinal products: Life cycle

-Technical evaluation: the pharmaceutical quality

-Control of quality: when and why?

II-Scientific Guidelines for Human Medicinal Products

 Guidelines and Eudra texts

Pharmacopeias, EMEA/ICH/QWP,  Eudralex

III-Quality Assurance

IV-Control of raw materials, container systems and labels

V-Control of the finished product

Practical

Quality control of different dosage forms.

Head Lecturer(s)

Eliana Maria Barbosa Souto

Assessment Methods

Assessment
Resolution Problems: 30.0%
Exam: 70.0%

Bibliography

Ph. Eur, US Pharmacopeia,
Portuguesa, C. d. F. (2012).Farmacopeia Portuguesa. Lisboa, Infarmed.
Prista, L., L. Morgado, et al. (1995).Tecnologia Farmacêutica I, Fundação Calouste Gulbenkian.
Prista, L., R. Morgado, et al. (1995).Tecnologia Farmacêutica II. Lisboa, Fundação Calouste Gulbenkian.
Prista, L., R. Morgado, et al. (1995).Tecnologia Farmacêutica III. Lisboa, Fundação Calouste Gulbenkian.