Management and Quality Assurance

Recommended Prerequisites

Statistics, Galenical Pharmacy, Pharmaceutical Technology.  

Teaching Methods

Lectures and theoretical-practical 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 brief 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:

- Understand and apply the principles of GMP;

- Assess the influence of various factors (facilities, methods, people, documentation) in total quality;

- Identify the requirements for certification and accreditation;

- Collaborate in the definition and management processes to improve the effectiveness and efficiency of the organization in which they will be embedded.

- To know the guidelines for auditing the management systems;

- Know how to develop and interpreter a Quality Management Manual;

- Know develop and manage the manual of Good Distribution Practices and Good Pharmaceutical Practices. 

Work Placement(s)

No

Syllabus

Plenary lectures

- Introduction to Quality Management

- Concepts of Quality and its evolution.

- Models of Quality.

- Formalization of a system for quality

- Interpretation and implementation of ISO 9001:2015

- Good Manufacturing Practices (GMP)

- ISO / IEC 17025:2017 and Accreditation of Laboratories

- Characterization of the requirements

- Methodology for its implementation

- Principles of Good Laboratory Practice

- Methodology for its implementation

- Good practices in drug distribution

- Good Pharmaceutical Practices.

- Environmental management

- Requirements of ISO 14001:2015

- Methodology for assessing environmental aspects and impacts

- Requirements of ISO 19011:2018 -Guidelines for auditing management systems.

-Requirements of ISO 45001:2018 -Occupational health and safety management systems

Practical

- Elaboration and discussion of exercises and practical works

- Proposal for study visits to organizations within the scope of the curricular unit. 

Head Lecturer(s)

Amélia Catarina Fernandes Soares Vieira

Assessment Methods

Assessment
Theoretical and practical Continuous Evaluation: 30.0%
Exam: 70.0%

Bibliography

- Allport-Settle, M. J. –  Good Manufacturing Practice (GMP) Guidelines, 2009. Pharmalogika Inc.

- Cooper, B.N. – Good Manufacturing Practices for Pharmaceuticals. GMP in Practice, 2017. CreateSpace Independent Publishing Platform.

- Pires,  A.R. – Sistemas de Gestão de Qualidade. 2ª Ed, 2016. Edições Sílabo

- Sarker, D.K. – Quality Systems and Control for Pharmaceuticals, 2008. John Wiley & Sons, Ltd

- Akyar, I. GLP: Good Laboratory Practice (2011). GLP: Good Laboratory Practice, Modern Approaches to Quality Control, Ahmed Badr Eldin, IntechOpen (DOI: 10.5772/19823)

- Boas Práticas Farmacêuticas para a Farmácia Comunitária (2009). Conselho Nacional da Qualidade Ordem dos Farmacêuticos

- Boas Práticas de Distribuição Farmacêutica (https://www.infarmed.pt/documents/15786/17838/11048532.PDF/4bde6495-b33d-4311-8302-784be4a65971) https://www.ordemfarmaceuticos.pt/fotos/editor2/Eventos/iRACI/Apresenta

- Norma ISO 9001:2015

- Norma ISO 14001:2015

- Noma ISO 17025:2017

- Norma ISO 45001:2018