GMPS και συστήματα διαχείρισης ποιότητας στο φαρμακευτικό κλάδο
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Keywords
GMP ; Συστήματα διαχείρισης ποιότητας ; QMS ; Ψηφιοποίηση ; Φαρμακευτική βιομηχανίαAbstract
Any progress in the production process needs digitalization as it is a key step in its development. The digitalization process includes both flexibility to change, productivity and efficiency improvement, computerization and automation solutions, thus enabling cost reduction as well as increased use of robotics. The pharmaceutical industry (PI), however, has been resistant to digitalization, mainly due to its complexity and fair experience involving manufacturing and development processes. Nevertheless, there is a clear need to digitize the pharmaceutical industry which is constantly growing as demand for both new and traditional medicines. Contract Manufacturing Development Organizations (CDMOs) have a particular digitalization challenge. The digitalization of the pharmaceutical industry and especially the CDMO, must be closely related to the main aspects of Good Manufacturing Practice (GMP). To be able to succeed in the pharmaceutical industry, digitalization requires a constant focus on GMP. Another important factor that needs to be in focus when digitizing the pharmaceutical industry is working closely with ever-changing stakeholders. This thesis presents an overview of the key aspects of digitalization in the pharmaceutical industry with an emphasis on good manufacturing practice and quality management systems, while discussing both process challenges and opportunities, focusing on practical solutions for sequential digital implementation.
Postgraduate Studies Programme
MBA TQM International - Ευρωπαϊκό Πρόγραμμα Μεταπτυχιακών Σπουδών στη Διοίκηση Επιχειρήσεων – Ολική Ποιότητα με διεθνή προσανατολισμό (MBA TQM Int)Department
Σχολή Οικονομικών, Επιχειρηματικών και Διεθνών Σπουδών. Τμήμα Οργάνωσης και Διοίκησης ΕπιχειρήσεωνNumber of pages
120Language
GreekCollections
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Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα
Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα