Cover: In the pharmaceutical industry, digitalization involves developing and implementing digital technologies at all levels of pharmaceutical operations. The aim is to transform the industry by capturing, analyzing, and using vast amounts of data collected from a wide range of sources to support research and development, clinical development, drug manufacturing, supply chain management, patient engagement, quality assurance and quality control, product safety monitoring, and other objectives.
Feature: Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 5 are applicable to a variety of life sciences organizations supporting or performing GxP-relevant activities. However, specific guidance on how to implement all the necessary measures and what to prioritize in small and medium sized enterprises is scarce.
Feature: The ISPE France Affiliate is fortunate in many ways. The pharmaceutical industry in France is world class, employing close to 100,000 people and generating €55.9 billion in annual revenue. The Affiliate’s membership runs the gamut from students and Young Professionals to industry veterans with expertise in research and development, engineering, manufacturing, and regulatory guidelines.
Technical: This article discusses quality and regulatory hurdles in the life cycle of a process analytical technology application— including model life-cycle management—in combination with continuous manufacturing for small and large molecules, with the goal of proposing strategies to resolve each challenge.