Clinical Supplies Manufacture

Pack, Brian W.; Stithit, Suchinda; Ray, Lisa; Chen, Wei; Zheng, Jack; Hwang, Richard

doi:10.1016/b978-0-444-53242-8.00025-4

Cited by 1 publication

(1 citation statement)

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“…For example, substituting a data-entry book with a tablet at a visual inspection workstation is straightforward to learn and adds value through efficiency. Identify projects that will need more effort but will provide significantly greater benefit while these activities are underway ( Pack et al, 2009 ). Completely revamping a traditionally paper-based, manual data-transfer system, for example, is significantly more difficult.…”

Section: The Digitization Process In Contract Development Manufacturing Organizations (Cdmo)mentioning

confidence: 99%

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

Hole

Hole²,

McFalone-Shaw

2021

International Journal of Pharmaceutics: X

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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.

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Section: The Digitization Process In Contract Development Manufacturing Organizations (Cdmo)mentioning

confidence: 99%