Industry 4.0 Elements for Pharmaceutical Development and Manufacture

Authors : Buket Aksu, Gizem Yeğen

Pages : 45-50

View : 13 | Download : 7

Publication Date : 2021-01-31

Article Type : Other

Abstract :The innovations of the Industry 4.0 revolution in the New World aimed at creating a society where we can solve many problems in every sector and social life. As a condition for Industry 4.0, industrial sectors are heading towards digitalization and automation. Pharmaceutical Industry takes its share in this sense and tries to keep up with this pace in the context of Pharma 4.0 which is a hot topic. However, it is a known fact that developing safe and effective new treatments is a long, difficult and expensive process, so FDA released the Pharmaceutical cGMPs for the 21st-century report and in this report; it specified Quality by Design (QbD) and Process Analytical Technologies (PAT) initiative to bring a solution. The introduction of the new QbD approach, which advocates providing the quality within the product with design instead of testing, brought an increase in the quality of the products manufactured, a decrease in costs and accelerated the market launch of the medicines. Moreover, patient safety is brought to the fore with better quality medicines and the patient accesses the drug in a shorter time.
Keywords : Industry 4.0, pharma 4.0, QbD, PAT, pharmaceutical development, pharmaceutical manufacture