Operations Management and Logistics

Gestão Operacional e Logística

Curse code:9494332

Konstantinos Saccás

Learning outcomes of the curricular unit:

• Acquisition of general knowledge on Operational Management and Logistics
• Application of this knowledge in the pharmaceutical sector

Syllabus:

1. Introduction
2. Site Master File
3. Industrial Pharmaceutical facilities
4. Clean rooms
5. Architecture and type of materials
6. Air filtration system
7. HVAC (heating, ventilation, and air conditioning)
8. Examples of a unit for oral solid forms and a unit for sterile
9. Purified Water System
10. Activity of Maintenance
11. Maintenance of Facilities
12. Qualification of facilities
13. Choice of industrial equipment
14. Qualification of equipment and systems
15. Laboratory Quality Control
16. ERP
17. Qualification of computer systems
18. Logistics

Suggested Bibliography:

• Eudralex, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary use
• ISPE Baseline, 1st edition, February 1998 – Pharmaceutical Engineering Guides for New Facilities – Volume 2: Oral Solid Dosage Forms
• ISPE Baseline, 1st edition, January 1999 – Pharmaceutical Engineering Guides for New Facilities – Volume 3: Sterile Manufacturing Facilities
• ISO 14644 : 1999, part 1. Clean rooms and Adjacent Facilities
• ISPE Good Practice Guide: Heating, ventilation and air conditioning (HVAC)