Tag Archive: Drug Manufacturing

LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING

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…

LESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING

February 12, 2024 || Brian Stephens
 
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 Software Assurance guidance in September 2022. Since that time, I have used this guidance to reduce the effort and cost required to complete two large…

Revolutionizing Drug Manufacturing: A closer look at pending Facility Applications for GMP Inspections

November 10, 2023 || Connie Leech and Geraldine Carr-Mulry
 
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, drug shortages have persisted on a global scale. The demand for flexibility in the supply chain remains imperative, However, many drug manufacturers are still reluctant…