LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 3 –SUMMARIZING
This is the last installment of a three-article series that presents several lessons learned by our validation team while completing a pair of validation projects...
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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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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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LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer...
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Revolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections
COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. Whilst certain aspects of the pandemic have gone away,...
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