Data Integrity in Pharmaceutical Quality Control Laboratories: What You Need to Know Q&A
Data integrity problems in pharmaceutical quality control laboratories are driving more regulatory action than ever before. It is obvious that something has changed to drive all this activity. There is plenty of information available, but much of it seems to confuse or frustrate rather than clarify or help. In this summary, we will provide clarity, dispelling confusion by looking at the facts, based on a study of available resources and direct interactions with FDA staff and their consultants. You’ll learn from Loren Smith, Agilent’s software compliance expert and a UC Berkeley instructor with 25 years of regulated software experience, how to put the current enforcement environment in historical context, and to apply critical thinking skills to what you hear or read regarding data integrity. You’ll also learn how to evaluate your current laboratory software and associated processes against these new expectations, as well as how vendors are redesigning laboratory software to help you respond to these new realities.
The Benefits of Custom Bonded Silica
April 1st 2025Not all chromatography resins are created equal. Off-the-shelf chromatography resins might not always meet the rigorous purification requirements of biopharmaceutical manufacturing. Custom bonded silica from Grace can address a wide range of separation challenges, leading to real performance improvements. Discover more about the latest innovations in chromatography silica from Grace, including VYDAC® and DAVISIL®.
5 Things to Consider When Selecting a Chromatography Silica
April 1st 2025Particularly in the pharmaceutical industry, drug purity isn’t just a goal – it’s essential for achieving safety, stability and efficacy. However, purification is easier said than done, especially with challenging molecules like DNA and RNA “oligonucleotides,” due in large part to their diversity and the range of impurities that can be generated during production. Enter DAVISIL® chromatographic silica, with a wide range of pore diameters and particle sizes to meet your specific application, performance and sustainability requirements. Before you choose the chromatography resin for your next purification application, take a look at these 5 considerations.
Automating Protein Purification: Efficiency, Yield, and Reproducibility
March 27th 2025Recent advancements in automated protein purification stress the importance of efficiency, scalability, and yield consistency. This eBook compares different purification platforms, highlighting their impact on downstream applications and demonstrating how automation enhances throughput and process control.
MilliporeSigma: Ultrapure Water for Sensitive LC-MS Analysis of Pesticides
March 25th 2025The aim of the study was to illustrate the efficiency of Milli-Q® water purification systems in eliminating pesticides from tap water, thereby producing and delivering reliable and consistent-quality ultrapure water suitable for pesticides analysis
