Validation, Commissioning & Design Featured Articles
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Is It Time To Move On From Your MES Vendor?
11/22/2023
Are you ready to improve your cloud-based solutions? Here are 6 indicators that you are ready to move your manufacturing processes forward with Modern MES.
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Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
11/16/2023
With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.
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The Power And Potential Of RBM In Clinical Trials
11/8/2023
Risk-based monitoring increases overall trial oversight by balancing “must-do” data collection and “nice-to-have” data against site and patient burden — and, more importantly, patient safety.
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The Problems With Construction Quality In Life Sciences
11/7/2023
In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.
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In Silico Approaches Towards Automated Biomanufacturing
11/6/2023
As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.
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Nitrosamine Impurities Deadline: Are Your Products Compliant?
11/6/2023
The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.
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Human Performance Theories And SOPs: Human Error Prevention In Manufacturing
11/3/2023
Standard operating procedures (SOPs) are often viewed as mere documents to be followed, rather than as dynamic tools. Drawing on human performance theories, this article explores how to create, review, and train on SOPs, as well as how manufacturing and quality teams can collaborate to improve oversight, all with human error prevention in mind.
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FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance
11/2/2023
As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.
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Three Ways Manufacturing Excellence Drives Value For Life Sciences
11/1/2023
Check out three ways Honeywell’s Manufacturing Excellence Platform delivers value in terms of costs, revenue, and risk.
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Digitalizing Biopharma Manufacturing Step-By-Step: Part II
11/1/2023
Explore a modular approach to digitalization involving the development of electronic logbooks and procedural guides, weigh and dispense processes, and Master Batch Records/Electronic Batch Records.