Pharma 4.0

Features

In this article, potential Pharma 4.0™ technological solutions that can enhance continuous process verification (CPV) 4.0 are discussed. The necessary paradigm shift will allow companies to predict deviations more accurately, perform root cause analysis (RCA), ensure data integrity and GxP compliance, and ultimately be more competitive in a highly regulated industry.

Video
Community of Practice The ISPE Pharma 4.0™ Community of Practice (CoP) is comprised of ISPE Members engaged in implementing Pharma 4.0™ principles in their organizations or simply wanting to learn more about the concepts...
Technical

Three case studies on Validation 4.0 demonstrate how quality by design (QbD) principles, when applied with digitization, can verify processes in scale-up and technology transfer, and why blend and content uniformity matter for tablet integrity.

iSpeak Blog

The Covid pandemic has pushed all companies to accelerate their digitization plans and ramp up adoption of emerging technologies. For regulated companies like Pharma, which operated in secure offices and fortified offshore development centers, this has also meant new ways of working and additional challenges in cybersecurity. Furthermore, with the need for agility in cases like developing the...

iSpeak Blog

ISPE’s Pharma 4.0™ initiative provides guidance, aligned with the regulatory requirements specific to the pharmaceutical industry, to accelerate Pharma 4.0™ transformations. Also known as the Smart Factory, the objective of Pharma 4.0 is to enable organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of...

Video
ISPE Expert Xchange is a new interactive, collaborative experience that unites forward-thinking pharma professionals with engaged subject matter experts for immersive, topic-focused events. Benefit from years of...
Features

This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical Engineering.1

  • 1Herwig, C., et al. “Data Science for Pharma 4.0™, Drug Development, and Production—Part...
Online Exclusives

Robotic process automation (RPA) software automatically handles manual, repetitive, time-consuming, and highly structured tasks such as data entry and back-office functions. Certain processes specific to the pharmaceutical industry represent strong candidates for RPA implementation, with significant potential savings and the possibility of ensuring compliance.

Guidance Docs
1 Introduction Within the pharmaceutical industry one sees a general drive toward utilizing data across all parts of the value chain. This implies...
Online Exclusives

Industry 4.0 is the recent movement toward intelligent automation technology. In this new era, the integration of modern manufacturing skills and novel information technologies plays an important role on economic competitiveness.1

  • 1Zawadzki, P., and K. Żywicki. “Smart Product Design and Production Control for Effective Mass Customization in the Industry 4.0 Concept.” Management and...