INSIGHTS ON QUALITY CONTROL
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ICH Q9 Revision 1: Enhancing Quality Risk Management
ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
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Cloud Migration In Regulated Environments: Validation Implications And Best Practices
Cloud adoption is essential for BioPharma growth, offering scalable tools for faster research. Success requires a risk-based approach to ensure data integrity and GxP compliance during the shift.
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Practical Considerations For Aseptic Gowning In Contamination Control Strategies
Master the complexities of aseptic gowning and Annex 1 compliance. Explore risk-based strategies to mitigate human-source contamination and strengthen your facility's sterility assurance.
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CPhI North America 2026: CDMO Partnerships With Mikart
Event-driven blogs highlighting how sponsors can evaluate CDMO partnerships, outsourcing strategies, and formulation development discussions across major 2026 industry conferences.
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Expanding Capabilities In QC Analyses With Advanced LC Detection11/26/2024
Today's quality control (QC) labs need instruments that can accurately take on a wide range of tasks. Discover a system that allows QC labs to enhance their capabilities and achieve various goals.
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Track Microbial Contamination In Environmental Water3/5/2026
Microbial testing of environmental water demands efficient, contamination‑resistant workflows. Discover a membrane filtration technique that offers rapid, reliable colony isolation.
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance12/9/2024
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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Leachables Method Development, Validation And Relevant ICH References5/16/2025
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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Improved GLP-1 Receptor Agonist Peptide Recovery6/30/2025
Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.
QUALITY CONTROL SOLUTIONS
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A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).
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Pharmaceutical companies face cost, complexity, and speed pressures. Inspection solutions support quality and compliance with fill detection, weighing, foreign body detection, and label verification.
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Advance organizational expertise with structured training designed for technical mastery. Explore specialized lessons that empower teams to optimize complex workflows and maintain compliance.
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Are you using obsolete or aging instruments simply because they continue to work? Running your laboratory with outdated technology brings about challenges beyond just headaches. Older technology may limit your performance, increase your costs, and open your lab up to risk. It may be time to investigate the real cost of using obsolete technology.
With the Waters FlexUP Technology Renewal Program, always work with the latest technology for optimum productivity and security.
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Developed for plasma protein binding determination and free fraction analyses, the Supel™ BioSPME 96-Pin Devices greatly improve upon the speed and simplicity of current sample preparation techniques.