Facility inspections continue to be on the minds of both drug manufacturers and regulators. Over the past year, we’ve discussed the challenges surrounding inspections in our Maintaining Quality and Supply…
During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…
Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…
Have other areas in drug discovery suffered because of COVID-19? It’s probably not too early to say that COVID-19 has changed pharmaceutical drug discovery considerably. And why wouldn’t it have,…
In December 2019, China issued a revision to their Drug Administration Law. It was the most wide-ranging modification of their laws since 2001. It marked a fundamental shift away from…
The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…
The International Council for Harmonisation (ICH) is an organization which brings together the pharmaceutical industry and regulatory authorities to improve the synchronization of industry regulations. The organization’s ultimate goal is…
Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…
Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…
In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…
