Quality in Pharmaceutical Sciences

Qualidade em Ciências Farmacêuticas

Course code:9494526

Maria Helena de Sousa Barroso

Learning outcomes of the curricular unit:

Provide students with the theoretical and practical concepts related to Quality in different areas of pharmaceutical practice, namely, pharmaceutical industry (from research and development to distribution and sales, through production and quality control), laboratory sciences, and community and hospital pharmacy.
It is intended that students learn strategies of quality assurance of the manufactured products or the services provided, or review and apply concepts acquired in other curricular units, and to promote:

• The acquisition and development of research attitudes and reflection
• Group work and, simultaneously, develop individual leadership and communication skills, as well as critical thinking

Syllabus:

1. GENERAL
   Quality Control, Assurance and Management
   Good Manufacturing and Distribution Practices / Laboratory / Hospital and Community Pharmacy
   Certification, Accreditation, Qualification and Validation. Application to different pharmaceutical areas
2. PHARMACEUTICAL INDUSTRY
   Good manufacturing practices: Personnel, Facilities and equipment, Documentation, Production and Quality control, Complaints and product recall, Self inspections
   Sampling. Validation. Statistical methods in quality control. Quality by design. Stability testing and influential factors in chemical, physical and microbial degradation
   Microorganisms and their products in biological assays. Microbiological control of immunological products. Non antibiotic antimicrobials. Evaluation of disinfectant and preservatives activity. Microbial ecology in industry
3. LABORATORY SCIENCES AND CLINICAL PATHOLOGY
   Structure and organization of the laboratory. Minimum quality requirements.
4. HOSPITAL AND COMMUNITY PHARMACY
   Management and organization of Hospital Pharmaceutical Services and Community pharmacy. Good practices

Suggested Bibliography:

• Nally JD (ed) (2007) Good Manufacturing Practices for Pharmaceuticals, 6th ed., Informa Healthcare, Inc., New York. ISBN: 9780849339721
• Sandle T (2016). Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control. 1st ed. Woodhead Publishing. ISBN-13: 978-0081000229
• Sharp J (2000) Quality in the manufacture of medicines and other healthcare products, The Pharmaceutical Press, London. ISBN: 9780853694311.
• Jacobsen TM, Wertheimer AI (2009) Modern Pharmaceutical Industry: A Primer. Jones and Bartlett Publishers. ISBN: 9780763766368.
• Farmacopeia Portuguesa 9 e suplementos (2008) INFARMED [CD Rom].