ISPE Pharma 4.0™ SIG & Its Working Groups
Cover: 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 SIG addresses how pharmaceutical industry stakeholders, including regulatory authorities, can achieve benefits from Pharma 4.0™ initiatives.
Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™
Feature: 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.
Data Science for Pharma 4.0™, Drug Development, & Production—Part 1
Feature:The article hypothesizes that data science–derived manufacturing process and product understanding is the main driver of digitalization in the bioprocessing industry for biologics manufacturing. In this article, the first of a two-part series, the authors analyze the prerequisites for establishing data science solutions and present key data science tools relevant to the process development stage.
Breaking with Tradition: Laying the Foundation for Validation 4.0
Feature: If Industry 4.0 is to succeed in the pharma space as Pharma 4.0™, we need new paradigms for validation across the value chain that use new technologies to improve product quality and the safety of medicines and treatments for the patient. This article lays the foundation for shifting our mindset and achieving Validation 4.0.
Technical: Automating MACO Calculations in Cleaning Validation For a multiproduct facility where equipment is shared, there is always risk from cross-contamination. The correct calculation of the cleaning validation limits from maximum allowable carryover (MACO) of a marker compound to the next product is vital for the integrity and success of the cleaning validation program. However, the process yielding those limits often involves cumbersome, error-prone manual calculations. The article describes an innovative yet simple tool that uses a combination of spreadsheet software and a statistical platform to fully automate science- and risk-based MACO calculations in pharmaceutical cleaning validation.