In today’s pharmaceutical industry, Quality by Design (QbD) has become an essential – instead of optional – tool. In fact, the phrase, “essential instead of optional” reminds me of the…
Continuous drug manufacturing is reported to have begun with Novartis and MIT a decade ago, but no one would dare argue that it’s taken off like a rocket ship in…
A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…
I was asked recently what a contract manufacturer such as Neuland Labs saw as the key differences with orphan drug projects. Neuland approaches orphan drug projects slightly differently from our…
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…
It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management. The consensus seems to be that the FDA shifted the responsibility…
Genotoxic impurities were around long before humans first began boiling bark. Our attempts to quantify, understand and control GTI formation, however, is a much more recent phenomena. It’s also a…
Hitting a milestone such as 30 years old as a pharmaceutical manufacturing company is a pretty big deal. Pharma – as you can imagine – has changed. A lot. Thirty…
Highly-Specialized Expertise Helps Pharma Focus on What They Do Best The discovery, manufacture and marketing of drugs is complex business indeed. So complex, in fact, that even the biggest of…
In February, FDA Commissioner Hamburg became the first-ever U.S. FDA commissioner to make an official visit to India. In a blog post back on February 11th – prior to her…