Blog
June 11, 2024 || Robert Ossig
The Planning stage of technology transfer (TT) is crucial for ensuring a seamless transition of processes, resources, and knowledge from the Sending Unit (SU) to the Receiving Unit (RU). However, this stage involves complex coordination across functional groups, each with unique roles and responsibilities. This blog explores the key activities…
May 22, 2024 ||
CAI’s best-in-class verification and risk management practices combined with Fedegari’s innovative sterilization equipment and engineering to reduce cost and accelerate speed to market INDIANAPOLIS (May 21, 2024) – CAI, a global company that provides technical, operational consulting, and project management services, today announced its strategic partnership with Fedegari Group, a…
May 1, 2024 || Charles Logan
Efficient communication stands as a cornerstone of thriving project teams, enabling the smooth exchange of thoughts, ideas, and emotions among members. Nevertheless, communication mishaps can occur despite diligent efforts, resulting in misunderstandings, conflicts, and missed collaborative opportunities. While factors such as language disparities and cultural distinctions contribute to these errors,…
April 26, 2024 || Robert Ossig
An Overview of the Execution Stage The Execution stage is the heartbeat of pharmaceutical technology transfer, 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, we delve…
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…
