INSIGHTS ON QUALITY CONTROL
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Aseptic Expertise And Delivery Of Services
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
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Compressed Gas Risk Assessment: A Significant Step In Your CCS
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.
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Development Of Separation Methods For GLP-1 Synthetic Peptides
Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.
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Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements
Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.
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Understanding cGMPs For Phase 1 Investigational Drugs8/15/2025
Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.
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Data-Driven Methods for Ensuring Container Closure Integrity12/18/2024
An integral component to a robust quality control program is container closure integrity testing (CCIT), which helps ensure the prevention of contamination and/or the degradation of a product.
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Achieving Licensing For A Healthcare Solution6/16/2025
Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.
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A New Framework For Identifying Nitrosamine Risks And Derisking Products6/18/2024
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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Water Activity And Primary Packaging For Oral Solid Dose Products7/10/2024
The draft of the general chapter USP<922> says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.
QUALITY CONTROL SOLUTIONS
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The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
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When you need a reliable partner to advance your molecule through development and testing, trust Cambrex to guide you toward the most efficient, high-quality solution.
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Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.
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Grow and scale up your manufacturing with the right support, and choose from 92,000+ chemicals provided through an extensive global network of 3,500+ manufacturers.
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Discover a system that addresses the issues faced by Quality Control (QC) labs with first-time quality (FTQ) results, shortened release cycles, and fewer investigations.