Read, Learn, Innovate: Pharmaceutical Engineering® Articles on Pharma 4.0™
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some of the many articles published about Pharma 4.0™. Now is a great time to catch up with Pharma 4.0™, especially with the upcoming 2022 ISPE Pharma 4.0™ and Annex 1 Conference in Vienna on 7–8 December.
ISPE Pharma 4.0™ SIG & Its Working Groups
The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The Special Interest Group addresses how pharmaceutical industry stakeholders, including regulatory authorities, can achieve benefits from Pharma 4.0™ initiatives.
The ISPE Pharma 4.0™ Operating Model’s - Pharma-Specific Maturity Index
ISPE’s initiative to transform industry-generic 4.0 models for pharma operations will help the industry benefit from digitalization.
Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™
The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of therapeutic medicines to patients, it is imperative that the pharmaceutical industry move deeper into the fourth Industrial Revolution and embrace increasingly advanced levels of digital maturity through Pharma 4.0™. This article discusses how holistic control strategy can be a bridge from established industry guidelines (ICH Q8–Q12) to the Pharma 4.0™ operating model.
Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing process verification (OPV). In the last decade, regulators have issued revised process validation guidance that puts more emphasis on demonstrating that pharmaceutical manufacturing processes remain in a state of control throughout the product life cycle by applying recurring data analysis
