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

Abstract

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.

Keywords: AIDS, Acquired Immune Deficiency Syndrome; CDMO, Contract Development and Manufacturing Organization; Contract development manufacture organization; Digitalization; EMA, European Medicines Agency; EU, European Union; FDA, Food and Drug Administration; GMP, Good Manufacturing Practice; ITA., International Trade Administration; MHRA, Medicines and Healthcare Products Regulatory Agency; PAI, Pre-Approval Inspections; PI, Pharmaceutical Industry; Pharmaceutical industry; Process improvements; TDM, Traditional Drug Manufacturing; USD, United States Dollars.