Management and Quality Assurance

Recommended Prerequisites

Statistics, Galenical Pharmacy, Pharmaceutical Technology. 

Teaching Methods

Lectures and theoretical-practical are taught to enable students to grasp selective and integrated scientific knowledge. Classes have the duration of sixty minutes and follow the model of masterful 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 data "show”. Simultaneously, the classes are available in Nónio. This system also provides other information relevant.

Learning Outcomes

The intention of this course is to impart knowledge to students to enable them:

- Understand and apply the principles of GMP;

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

- Know the Regulation of previous inspections and issuance of GMP Certification;

- Identify the requirements of the certification and accreditation;

- Collaborate in the definition and management processes to improve the effectiveness and efficiency of the organization in which will be inserted;

- To know the guidelines for auditing the management systems;

- Know develop a standard operating procedure;

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

Work Placement(s)

No

Syllabus

 Plenary lectures

- Good Manufacturing Practices (GMP)

- Introduction to Quality Management

- Concepts of Quality and its evolution.

- Models of Quality.

- Formalization of a system for  quality

- Interpretation and implementation of ISO 9001:2008

- ISO / IEC 17025 and Accreditation of Laboratories

- Characterization of the requirements

- Methodology for its implementation

- Principles of Good Laboratory Practice

- Methodology for its implementation

- Environmental management

- Requirements of ISO 14001:2012

- Methodology for assessing environmental aspects and impacts

 -Requirements of ISO 19011:2012 - Guidelines for auditing management systems.

 - Good practices in drug distribution

 - Good Pharmaceutical Practices.

Practical

- Preparation of works for oral presentation, referring to the Annexes of GMP

- Examples of practical application of different  studied quality standards

- Development of standard operating procedures.

Head Lecturer(s)

Maria Eugénia Soares Rodrigues Tavares de Pina

Assessment Methods

Assessment
Other: Theoretical and practical Continuous Evaluation: 20.0%
Exam: 80.0%

Bibliography

Boas Práticas Farmacêuticas, 3ª Edição, 2009/ Good Pharmaceutical Pratices,

Decreto-Lei n.º 99/2000, Princípios de boas práticas de laboratório (BPL)/ (GLP)

ISO 14001: 2012 – Sistema de gestão ambiental. / Environmental Management System. .

ISO 9001: 2008 – Requisitos de SGQ/ System requirements for quality management.

ISO/IEC 17025: 2005 – Requisitos gerais de competência para laboratórios de ensaio e calibração- Requirements for the competence of testing and calibration.

OHSAS 18001/NP 4397 – Sistema de Gestão de Saúde e Segurança no Trabalho/ Management of Health and Safety at Work.

Portaria nº 348/98, de 15 de Junho - Boas práticas de distribuição de medicamentos/ Good practices in drug distribution

Ramos Pires, A. Qualidade. Sistemas de gestão da qualidade. 3ª ed., Lisboa,: Sílabo, Lda. 2007./ The Quality. Systems of quality management.

 GMP:Part I – Boas práticas de fabrico/ Basic Requirements for Medicinal Products.