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Current Good Manufacturing Practices (cGMPs) are an essential aspect of compliance, and attention on them by regulators is growing. In today’s global pharma industry, it’s common to have multiple investigators…
We are firm believers that quality is more important than…well…everything in the pharma business. It’s very simple: in this highly-regulated industry, without quality – a company has no value. We…
One portion of an article at PharmTech (Five Themes That Will Drive the CMO Industry) discussing opportunities for smaller CMOs recently caught my eye. It mentioned that those aforementioned opportunities…
In the pharmaceutical discovery space, many promising analytical trends have emerged and are now on the rise – and they will see increasing use in drug discovery in coming years….
A genotoxic impurity (GTI) is a chemical substance that can directly or indirectly damage DNA or chromosomes and induce genetic mutations. Fifteen years ago, there were no specific guidelines for…
Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From…
Reducing Mutagens, Carcinogens & Other Genotoxins to Improve Safety Profiles There are a number of process modifications API manufacturers can make to improve safety profiles, reduce production costs, improve capacity…
Active Pharmaceutical Ingredients (APIs, or – in layman’s terms – the ingredients that makes drugs work) have grown increasingly complex. Today’s equivalent of boiling tree bark into a tincture typically…
Last week, we wrote a post on new analytical methods for the detection of impurities that our R&D group had developed for the drug Febuxostat. And we’ve done the same…
In this month’s issue of PharmTech, team members at Neuland’s R&D Center in Hyderabad published a peer-reviewed article on the analysis and management of impurities in the drug Febuxostat. Febuxostat, a…
