Hole Glenn, Hole Anastasia S, McFalone-Shaw Ian
Molde University College, Molde and Procuratio Consulting, Drammen, Norway.
Helseviten AS, Drammen, Norway.
Int J Pharm X. 2021 Oct 6;3:100095. doi: 10.1016/j.ijpx.2021.100095. eCollection 2021 Dec.
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.
任何制造业的数字化都是生产过程进步的关键一步。数字化过程包括更多地使用机器人技术、自动化解决方案和计算机化，从而降低成本、提高效率和生产力，并灵活应对变化。然而，制药行业一直抵制数字化，主要是由于相关开发和制造过程的经验不足和复杂性。尽管如此，随着传统药物和新药的需求不断增长，制药行业显然需要进行数字化。合同研发生产组织（CDMO）面临着特殊的数字化挑战。制药行业的数字化，准确地说是CDMO的数字化，应该与药品生产质量管理规范（GMP）的主要方面紧密相关，并且，要成功实现制药行业的数字化需要持续关注GMP。与不断变化的利益相关者密切合作是CDMO数字化过程中另一个需要关注的重要因素。本文概述了CDMO数字化的主要方面，并讨论了该过程的机遇和挑战，重点关注连续数字实施的实际解决方案。
