Digitalization in pharmaceutical industry: What to focus on under the digital implementation process?

• Published in: International journal of pharmaceutics: X Vol. 3; p. 100095
• Main Authors: Hole, Glenn, Hole, Anastasia S., McFalone-Shaw, Ian
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.12.2021; Elsevier
• Subjects: Contract development manufacture organization; Digitalization; Mini Review; Pharmaceutical industry; Process improvements; Digitalization; FDA; USD; Process improvements; AIDS; GMP; MHRA; Contract development manufacture organization; EU; ITA; EMA; PAI; PI; Pharmaceutical industry; CDMO; TDM
• ISSN: 2590-1567; 2590-1567
• DOI: 10.1016/j.ijpx.2021.100095

Digitalization of any manufacture industry is a key step in any progress of the production process. The process of digitalization includes both increased use of robotics, automatization solutions and computerization, thereby allowing to reduce costs, to improve efficiency and productivity, and to be flexible to changes. Pharmaceutical Industry (PI) has however been resistant to digitalization, mainly due to fair experience and complexity of the entailed development and manufacture processes. Nevertheless, there is a clear need to digitalize PI as the demand in both traditional and new drugs is constantly growing. Contract Development Manufacture Organizations (CDMOs) have a special digitalizing challenge. Digitalization of PI, and CDMO precisely, should be tightly related to the main aspects of Good Manufacture Practice (GMP), and, to succeed in PI digitalizing requires constant focus on GMP. Close collaboration with constantly changing stakeholders is another important factor which should be in focus during digitalization of CDMO. This paper represents an overview over the main aspects of CDMO digitalization and discusses both the opportunities and challenges of the process, focusing on the practical solutions for successive digital implementation. [Display omitted] •Nowadays Pharmaceutical Industry needs digitalization.•Manufacture digitalization is necessary for profitability, progress, and quality.•Good Manufacture Practice should be in focus under industrial digitalization.•To succeed with digitalization both opportunities and challenges should be in focus.