Editorial
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FDA Warning Letters Dipped, But Don’t Get Cozy
10/19/2023
Between October last year and March this year, FDA inspectors showed a heightened level of discretion for OAI inspections, choosing to withhold enforcement action. This isn't an invitation to breathe easy; there's a reasonable explanation for less enforcement action.
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Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses
10/18/2023
Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.
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Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations
10/12/2023
Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1
10/6/2023
All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.
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Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations?
10/6/2023
Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.
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Here’s Why Outsourcing To CDMOs Doubled In 13 Years
10/4/2023
It might surprise no one that BioPlan Associates' 20th annual survey on manufacturing found an increased dependence on contract manufacturing. The sheer rate at which demand has grown, however, is stunning, and the survey found CDMO capacity is only now starting to catch up with supply.
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Preformulation Of Excipients In Biologics Development
9/28/2023
Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.
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FDA Introduces Quality Management Maturity Program
9/26/2023
The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.
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Understanding The FDA’s Current Focus On Risk Evaluation And Mitigation Strategies
9/21/2023
The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.
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Essential Elements Of Technology Transfer
9/19/2023
The principles of an effective technology transfer can apply at every stage of the drug development lifecycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down.