2025
Quality Management in the Pharmaceutical Sector
Name: Quality Management in the Pharmaceutical Sector
Code: CMS13782I
3 ECTS
Duration: 15 weeks/78 hours
Scientific Area:
Ciências Farmacêuticas
Teaching languages: Portuguese
Languages of tutoring support: Portuguese
Presentation
This Unit intendeds to povide the students with the knowledge about the basic concepts and requirements of Quality Management (QM), particularly in the pharmaceutical area; understand the advantages and critical factors of its implementation and contact the process of evaluating a QM system.
Sustainable Development Goals
Learning Goals
With this CU it is intended that students obtain knowledge about the basic concepts and requirements of Quality Management (QM), particularly in the pharmaceutical area; understand the advantages and critical factors of its implementation and contact the process of evaluating a QM system.
Thus, the student should be able to:
1. Understand quality as a critical success factor;
2. Know the main methods, techniques and tools at the service of quality;
3. Know the methodologies used in the certification processes and basic standards;
4. Identify the various aspects related to Total Quality Management (TQM);
5. Know the specificities and implications of quality in organizations related to pharmaceutical activity;
6. Know standards, norms and important criteria in the different pharmaceutical area
7. Understand the relationship between QM and the legal requirements applicable to the different branches of pharmaceutical activity, at the national level.
Thus, the student should be able to:
1. Understand quality as a critical success factor;
2. Know the main methods, techniques and tools at the service of quality;
3. Know the methodologies used in the certification processes and basic standards;
4. Identify the various aspects related to Total Quality Management (TQM);
5. Know the specificities and implications of quality in organizations related to pharmaceutical activity;
6. Know standards, norms and important criteria in the different pharmaceutical area
7. Understand the relationship between QM and the legal requirements applicable to the different branches of pharmaceutical activity, at the national level.
Contents
Module 1- Introduction to Quality Management
1.1. Impact of Quality Management on the Life of an Organization
1.2. Quality concepts and their evolution
1.3. Total Quality Management (TQM) and continuous improvement
1.4. Quality Models and Tools
1.5 Methodology for implementing a quality management system
Module 2- Quality in health
2.1.- Components and specificities of quality in health
2.2.- Norms and standards of quality in health
2.3.- Health accreditation
Module 3- Quality Management and Pharmaceutical Activity
3.1. Quality Management in Community and Hospital Pharmacy
3.2. Quality Management in the Pharmaceutical Industry
3.3 Quality Management in Pharmaceutical Distribution
3.4 Quality Management in Clinical Analysis Laboratories
3.5 National legal requirements and quality management system - additions and interceptions. Good Pharmaceutical Practices
3.6. Case Studies
1.1. Impact of Quality Management on the Life of an Organization
1.2. Quality concepts and their evolution
1.3. Total Quality Management (TQM) and continuous improvement
1.4. Quality Models and Tools
1.5 Methodology for implementing a quality management system
Module 2- Quality in health
2.1.- Components and specificities of quality in health
2.2.- Norms and standards of quality in health
2.3.- Health accreditation
Module 3- Quality Management and Pharmaceutical Activity
3.1. Quality Management in Community and Hospital Pharmacy
3.2. Quality Management in the Pharmaceutical Industry
3.3 Quality Management in Pharmaceutical Distribution
3.4 Quality Management in Clinical Analysis Laboratories
3.5 National legal requirements and quality management system - additions and interceptions. Good Pharmaceutical Practices
3.6. Case Studies
Teaching Methods
Teaching / learning takes place by integrating: i) theoretical classes using expository methods and active pedagogy, as well as the presentation and discussion of practical cases; ii) practical classes for the presentation and discussion of group work presented by the students on one of the modules taught in the theoretical classes, carried out with the tutorial support of the teacher.
The use of e-learning resources allows the permanent updating of contents and the autonomous exploration of the most recent scientific developments.
Evaluation:
1. Continuous Assessment: practical component (40% of total), consisting of critical reflection in (30%) and group work related to one of the modules of the UC, with oral presentation (70%) + theoretical component (60% of total), composed of a final written exam (60%);
Or Final Assessment: final exam with practical and theoretical component (100%).
The use of e-learning resources allows the permanent updating of contents and the autonomous exploration of the most recent scientific developments.
Evaluation:
1. Continuous Assessment: practical component (40% of total), consisting of critical reflection in (30%) and group work related to one of the modules of the UC, with oral presentation (70%) + theoretical component (60% of total), composed of a final written exam (60%);
Or Final Assessment: final exam with practical and theoretical component (100%).
Certificações
