Validation, Commissioning & Design Featured Articles
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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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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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The Importance Of 503B Facilities In Drug Manufacturing Today
10/5/2023
Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.
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The Impact Of Digital QMS Solutions On The Life Sciences Industry
9/29/2023
Learn how integrated software solutions supported by a unified cloud environment dramatically improve operational effectiveness for the life sciences industry and solve many traditional challenges.
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Integration Of Quality Management And Manufacturing Automation Systems
9/29/2023
Quality by design (QbD) is enormously valuable but often underutilized, siloed, and not operationalized. Discover the benefits of enabling QbD with AI-driven quality operations and batch automation.
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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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Risk Tool Selection With ICH Q9(R1) In Mind
9/19/2023
This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.
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Demystifying Custom Media Development
9/13/2023
Explore four of the most common concerns surrounding custom media development, and how you can avoid potential challenges and get the most from custom formulations.
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Overcome Common Media Scalability Challenges
9/13/2023
Streamline the transition to commercial manufacturing through four key development considerations; format conversion, manufacturability, supply insurance, and batch-to-batch consistency.
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Bioproduction Analytics To Support Optimized Media Development
9/12/2023
Designing and optimizing a cell culture medium can be a complex and time-consuming process, and accurate analytics are vital in streamlining media development to achieve long-term success.