Pharmaceutical Manufacturing is Witnessing Major Transformation as New Demands for Sterility Assurance Reshape Healthcare

July 19, 2023
Alexandra Simon

 

For an industry where precision and quality control are paramount, pharmaceutical manufacturing is witnessing an evolutionary leap in contamination control practices. Propelled by changes in regulatory environments, such as the EU’s Annex 1 update and ICH Q9 focusing on quality risk management, the sector is shifting from isolated, data-point-centric strategies towards a more holistic approach. 

This transformation emphasizes the integration of various operational elements – from facility design to process controls – under a single, strategic umbrella of sterility assurance. As this shift towards comprehensive, AI and machine learning assisted processes reshapes the pharmaceutical manufacturing industry. Exploring this on “Exceeding Your Benchmark,” a podcast by Benchmark Products, is Fred Ayers. The Advisor for Sterility Assurance for Global Quality Systems at Eli Lilly is an industry expert, and shared some of his insights as he’s been at the forefront of this change.

 

Recent Episodes

Healthcare IT Renovation
View episode

Given the rise of digital transformation demands and the persistent challenges of cybersecurity, a healthcare IT renovation project can be pivotal as industry leaders actively seek guidance on navigating these complex waters. Why now? What makes the current landscape ripe for a Healthcare IT Renovation Project, and how does one tackle such a monumental…

advancing health equity
View episode

During the 2024 HIMSS Conference, an annual highlight for digital health innovators, Dr. Bryan O. Buckley, the Health Equity Director at NCQA, shared transformative insights on advancing health equity in digital healthcare. This interview, conducted by Healthcare Rethink host Brian Urban, delves into the strategies that can reshape healthcare delivery through technology and equity….

Validation
View episode

Validation and qualification are some of the most critical phases in the lifecycle of equipment and processes within industries like pharmaceuticals and manufacturing. Driven by the necessity to adhere to stringent regulatory standards and ensure high operational efficiency, the distinction between ‘qualification of equipment’ and ‘validation of processes’ becomes paramount. As the landscape of…