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 [...]
How to Prepare for a GMP Inspection for Small and Virtual Companies by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when [...]
An efficient summary of all things FDA/GMP related for the entire month of August 2018. Warning letters, a refusal of an FDA inspection, new guidance, etc. See the complete run down here.
The FDA posted 4 warning letters this week -- 2 of which were GMP letters to drug firms. One firm manufactures APIs and the other manufactures finished pharmaceuticals. This week we also saw 2 untitled letters posted from inspections in 2016 (yes, 2 years ago). We cover all 4 in this post.
Most of us feel comfortable with paper records. We like to think they’re the same as electronic records. But we hear rumblings from GMP inspections that FDA doesn’t always share that view. Let’s explore a simplified, hypothetical example to help you understand the importance of “content” and “meaning” and avoid an unnecessary 483.
The 2nd half of our dive into MHRA’s published revision to their 2015 Data Integrity Guidance. Changes are abundant when we compare the 2015 and 2018 versions. We share (in a clear table format) the final 23 updates along with our GMP expert’s conclusions.
A very busy week on the warning letter front! Six warning letters to API/pharma firms and 1 to a GLP firm for non-clinical studies. We cover all within this post.
I spoke to a former VP of quality at the PDA/FDA Joint Regulatory Conference. He said one of his bad 483s probably cost him $5 million. And that’s cheap – that’s just a 483. What about a warning letter? There is an even greater magnitude of reputation damage, impact on new drug approvals, etc. This post describes the full scope and includes articles/case studies.