Blog
April 26, 2024 || Robert Ossig
During a life sciences technology transfer (TT) project, the Execution Stage is the heartbeat of the overall effort, where the meticulous planning of the Readiness stage comes to fruition. This critical phase involves executing Process Performance Qualification (PPQ) and ensuring operational readiness and compliance at the Receiving Unit (RU). Here,…
April 26, 2024 || Geraldine Carr-Mulry
Annex 21 went into effect on August 21, 2022. It’s time to check that processes and procedures have not fallen short of the actual requirements specified in this guideline and to consider whether this guideline has helped manufacturers, healthcare providers, and patients. So, what is Annex 21? Annex 21 details the GMP…
April 26, 2024 || LeAnna Pearson
Introduction: In a global community, studies are often conducted by testing facilities located outside of the United States of America, including countries such as Brazil, China, India, and Japan. The final test reports and accompanying documentation require translation from the facility’s native language to English when performing the testing. All…
April 15, 2024 || David Shenberger
The US Food and Drug Administration (FDA) has launched a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability. For innovative companies, this provides an exciting opportunity to improve processes and drive sustainability. This initiative is part…
April 3, 2024 || Cheryl Bondurant
When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I asked the question why should we focus on regulatory inspection remediation instead of prevention of inspection remediation? For those of you who have been involved…
March 18, 2024 || Connie Leech
Most people take for granted that medication prescriptions will be ready at the pharmacy counter and available for pick up when ordered to get themselves on the road to recovery. The COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. While some aspects…
March 18, 2024 || Connie Leech
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical products, thereby enhancing patient outcomes and overall satisfaction. Manufacturers can consistently deliver sterile medications and devices by employing state-of-the-art aseptic processing techniques, reducing the risk…
March 18, 2024 || Brian Stephens
This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects that used the FDA’s draft of the Computer Software Assurance for Production and Quality System Software Guidance (CSA). The number of resources, the amount of…
March 18, 2024 || Kevin Hawkins
This is the final installment of a three-part series exploring the transformative power of Virtual Twins as part of an asset induction effort for facility maintenance. The information in this series is based on the use of Virtual Twin technology for a biomanufacturing site, but the same principles could be…
March 18, 2024 || Kevin Hawkins
This is the second installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility maintenance. Part One of this series provided an overview of implementation of this technology and benefits once completed. Now, in Part Two we will address…
