Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing
Cover: Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization.
ICH Q13 and What Is Next for Continuous Manufacturing
Feature: The creation of a new ICH guidance document, Q13 [1], presents an opportunity for industry and regulators around the world to connect and develop harmonized regulatory expectations for the continuous manufacturing (CM) of drug substances and drug products, resulting in an increased likelihood of implementation across the globe.
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Feature: Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification technology, with investment expected to rise in the coming years and the focus shifting toward biologics. This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data and knowledge-centric approach to risk management can help CM achieve its full potential.
ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma
Technical: ChatGPT and other large language models are positioned to change the world. They can also shift acceptance and prevalence of machine learning solutions in regulated industries in general. However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective.
Air Change Rate Reduction during Operation: Success at Roche/Genentech
Technical: To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside facilities and Engineering team collaborated to implement a risk-based approach to achieve lower air changes during operation without adversely impacting the facility, equipment, or reliability, while meeting environmental requirements.