Category: GxP Consulting

Did COVID-19 Kill Just-in-Time Pharma Supply Chains?

The full impact of the pandemic has yet to be felt, and the intricate and proprietary nature of pharma supply chains prevents an overall industry analysis.  Considering the current reality, is the JIT model now dead or dying in the pharma industry?

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CDRH Reorganization Takes a Total Product Lifecycle Approach; MDSAP, ISO Adoption, and Collaboration with MDIC Moving Forward

In the third report from December’s FDLI Enforcement, Litigation, and Compliance Conference, CDRH’s Associate Director for Compliance and Quality Erin Keith explains the Center’s completely revamped organization structure that was finalized late last Fall, its progress on international harmonization efforts, and the changing face of its compliance program.

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FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations.  The other two firms manufacture OTC products.  FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.

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EMA Announcements Regarding Nitrosamine and MDRs

The EMA published information on two topics this week addressing changes in due dates and application dates regarding nitrosamine-related risk assessments and implementation of the new Medical Device Regulation (MDR) requirements.

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Part 3: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

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