Management and Quality Assurance

Recommended Prerequisites

Statistics, Galenical Pharmacy, Pharmaceutical Technology.

Teaching Methods

Lectures and theorectical-pratical are taught to enable students to selectively grasp and integrate scientific knowledge. Classes have the duration of sixty minutes and follow the model of expository lesson. The presentation of the syllabus of each class is always preceded by a bried introduction, which address the main objectives of matter, making up the connection with the previous lesson, if there is continuity. In the exhibition uses the "datashow". Simultaneously, the classes are available in Inforestudante or UCStudent.

Learning Outcomes

This course is intended to impart knowledge to students to enable them to:
- Develop skills in the context of quality management
- Identify the requirements of certification and accreditation standards
- Contextualize the international ISO standards and promote their implementation in the different sectors of pharmaceutical activity
- Collaborate in the definition and management of processes to improve the effectiveness and efficiency of the organization in which they will be inserted
- Understand and apply the principles of Good Manufacturing Practices
- Evaluate the influence of various factors (facilities, methods, people, documentation) on the total quality
- Understand Good Distribution Practices and Good Pharmaceutical Practices
- Know the guidelines for audits and management systems

Work Placement(s)

No

Syllabus

Theoretical:
- Introduction to Quality Management
- Quality concepts and their evolution
- Quality Models
- Formalization of a Quality system
- Interpretation and implementation of Noma ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018
- ISO/IEC 17025:2017 Requirements and Laboratory Accreditation
- Good Laboratory Practices
- Good Manufacturing Practices (GMP)
- Good distribution practices
- Good Pharmaceutical Practices
- ISO 19011:2018 requirements
Theoretical - Practical:
- Elaboration, presentation and discussion of practical works
- Proposal for study visit within the scope of the course

Head Lecturer(s)

Amélia Catarina Fernandes Soares Vieira

Assessment Methods

Assessment
Theoretical and Practical Continous Evaluation: 30.0%
Exam: 70.0%

Bibliography

- Allport-Settle, M. J. – Good Manufacturing Practice (GMP) Guidelines, 2009. Pharmalogika Inc.
- GMP: Part I -Basic Requirements for Medicinal Products : EudraLex - Volume 4 - European Commission
- Pires, A.R. – Sistemas de Gestão de Qualidade. 3ª Ed, 2023. Edições Sílabo.
- Sarker, D.K. – Quality Systems and Control for Pharmaceuticals, 2008. John Wiley & Sons, Ltd.
- Akyar, I., – GLP: Good Laboratory Practice, Modern Approaches to Quality Control, Ahmed Badr Eldin, IntechOpen (2011). (DOI: 10.5772/19823).

- Boas Práticas de Distribuição Farmacêutica.
- Boas Práticas Farmacêuticas para a Farmácia Comunitária.
- Norma ISO 9001:2015 - Sistemas de Gestão da Qualidade
- Norma ISO 17025:2018 - Requisitos gerais de competência para laboratórios de ensaio e Calibração.
- Norma ISO 14001:2015 - Sistemas de Gestão ambiental.
– Norma ISO 45001:2018 - Sistema de Gestão de saúde e segurança ocupacional.
- Norma ISO 19011:2019 - Linhas de orientação para auditorias a sistemas de gestão.