Category Archives: biopharma

What Does Getting a 483 or Warning Letter Really Cost You?

“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”

I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world.  While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483.  And then what happens after that? Continue reading

Data Integrity cGMP FDA draft guidance

FDA Draft Guidance on Data Integrity and Compliance With CGMP

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief

 

The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.  I include links to the MHRA guidance HERE and the draft WHO guidance HERE for comparison.  The guidance is structured in a Q&A format with a total of 18 questions.  This guidance focuses heavily on identifying and citing the predicate rules as they apply to electronic records and data integrity, and for this it is an excellent reference.  In my opinion, though, the excessive citation of regulations detracts from the content and provides little insight into FDA’s intent and actual expectations in this area.

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PRESS RELEASE: New Data Provides FDA-Regulated Industries Unprecedented Insights Into FDA Inspection Trends and Enforcement Actions

CHICAGO, IL – May 14, 2015

FDA Inspections at a glanceToday, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity.  For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked together, creating huge potential for industry insight.

“Smart data has arrived onto FDA inspections.  We are proud to unveil Enforcement Analytics today, a much-needed innovation in the regulatory space for the thousands of professionals who work on keeping their manufacturing processes up to snuff for the FDA,” said Tony Chen, co-founder and CEO of FDAzilla. Continue reading

We Learned 5 Things from 2014 FDA and EU GMP Drug Enforcement Actions

2014 proved to be another busy year for the FDA.  We asked Barbara Unger, President of Unger Consulting and Editor-in-Chief of GMP Regulatory Intelligence, to summarize her key take-aways from the enforcement actions of the FDA and EU in 2014. Here’s Barbara: Continue reading

4 Trends About GMP Inspection Readiness and FDA Data Intelligence

I hope you read our recent post about the backstory of our company, FDAzilla. We’ve come a long way in 5 years. As we plan for the next 5 years, we’ve been preparing for our annual executive team meeting in April.  As such, our team researches and synthesizes the most important trends to which we must respond and adapt. Continue reading

3 Questions with Barbara Unger

Yesterday was Part I. Today, we get to hear a little more from Barb on her background.Barbara Unger

What publicly available information do you depend on for your job? How do you use that information?

I focus primarily on the US, EU, ICH and PIC/S. For laws, regulations and guidance the regulator specific websites publish information quickly. The ICH and PIC/S websites also publish their guidance in an organized way. Compliance actions taken by FDA and EMA are also published. I also read publications in the major newspapers and several blogs. Sometimes the best information can come from an unanticipated source. Continue reading