The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably busy with a million things on your to-do list. And while you know you should set up a complete FDA inspection preparedness program, you just [...]
Homeopathic Products: What Are They and Why Should You Care? by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Among the unique enforcement actions in fiscal year 2017 are a cluster of warning letters and recalls of homeopathic products. 2017 saw as many warning letters issued to these firms as were issued between 2009 and 2013. This is a [...]
by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Acquisition of one pharmaceutical firm by another is preceded by due diligence efforts in many functional areas. Let’s talk about activities in the GMP area. Firms may not be able to fully rely on past inspections by the FDA to predict the extent of remediation that might be necessary [...]