INSIGHTS ON QUALITY CONTROL
-
Building Control Strategies: It's Time To Go Digital
Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.
-
Seamlessly Integrating An E-WorkBook With A Customer's LIMS
Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.
-
Essential Insights Into Pharmaceutical Product Release: Part 2
Optimizing pharmaceutical product release requires effective planning, specification development, electronic systems, and collaboration with CMOs, ensuring compliance, efficiency, and quality in the drug manufacturing process.
-
Achieving Licensing For A Healthcare Solution
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.
-
Leveraging A Modern HPLC System For Peptide Drug Substances Analysis8/22/2024
This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.
-
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.
-
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.
-
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.
-
Practical Solutions For Protein Analytics And Residual DNA Testing11/12/2025
Discover practical solutions for common quality control bottlenecks in biotherapy manufacturing. Learn how to improve protein analytics and DNA testing robustness and accelerate time to market.
QUALITY CONTROL SOLUTIONS
-
Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs testing in the course of pharmaceutical quality control. Test methods being used are the rabbit pyrogen test (RPT), the bacterial endotoxin test (or LAL test), and the monocyte activation test (MAT).
-
To monitor product quality effectively, it’s critical to test for microbial contamination throughout manufacturing. Discover an easy-to-use, non-destructive, fluorescent staining-based system for faster microbial detection.
-
Explore chromatography methods for sample preparation, residual solvent, and impurity analysis, critical steps for Active Pharmaceutical Ingredient (API) quality control.
-
Our newly expanded in-house capabilities span clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays.
-
Discover your digital QC companion for sterility testing and other regulated processes. Ensure full traceability and regulatory compliance with contemporaneous, automatic, and complete recording of QC testing data.