The Execution Stage of Technology Transfer
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...
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Annex 21 – Are we on track and is there an impact?
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...
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Translating Study Reports – A GLP Draft Guidance
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,...
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FDA’s Advanced Manufacturing Technology Program: Accelerating the Drive to integrated Automated Manufacturing
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...
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Patient Safety is the Perspective for Prevention
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...
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Supply Chain Resilience
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...
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Patients emerge as the ultimate beneficiaries of Aseptic Processing Technology advancements
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical...
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LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING
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...
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Transformative Power of Virtual Twins (Part 3 of 3)
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...
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Transformative Power of Virtual Twins (Part 2 of 3)
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...
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