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The Initiation Stage of Technology Transfer

June 11, 2024 || Robert Ossig
 
In the complex landscape of pharmaceutical and biopharmaceutical product development, the initiation stage of technology transfer (TT) is critical for ensuring successful scale-up and manufacturing. This stage involves a multidisciplinary approach, where business, technical, and regulatory considerations must be meticulously assessed to determine the feasibility and strategy for TT. Effective…

The Planning Stage of Technology Transfer

June 11, 2024 || Robert Ossig
 
The planning stage sets the foundation for a successful technology transfer. It begins when the site selection decision is made and the initial charter has been approved and marks the start of knowledge transfer from the sending unit (SU) to the receiving unit (RU). The planning stage involves collaboration between…

CAI and Fedegari Group Forge Strategic Partnership to Deliver Transformational Turnkey Sterilization Solutions to Pharmaceutical Manufacturers

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…

Exploring Sources of Communication Errors in Project Teams

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,…

The Execution Stage of Technology Transfer

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…

Annex 21 – Are we on track and is there an impact?

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…

Translating Study Reports – A GLP Draft Guidance

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…

FDA’s Advanced Manufacturing Technology Program: Accelerating the Drive to integrated Automated Manufacturing

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…

Patient Safety is the Perspective for Prevention

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…

Supply Chain Resilience

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…