FDA Inspection Preparation, Supply Risk Management, FDA Guidance, and More…
We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter. Device manufacturing violations ranged from failing to evaluate complaints to failing to establish [...]
“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”
While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.
The FDA posted 9 warning letters this week including 1 to a device manufacturer, 1 each to an API manufacturer and compounding pharmacy, and, finally, 2 to finished dosage form manufacturers.
An efficient summary of all things FDA/GMP related for the week of 7/29/18. FDA, EMA, etc. have picked up the pace for laws/published docs. Same with warning letters (5 issued). See the complete run down here.
“When I started in the industry back in 1990, I was a statistical programmer. While none of us used the phrase ‘data integrity,’ the way we worked helped ensure data integrity.” This post dives deep into these questions: What game changing regulatory action happened in 1997? Why do we validate computer systems? Are there any regulatory provisions for draft GLP or draft GCP data?
In the past 2 weeks we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.