Category Archives: CGMP

Data Integrity: The Whole Story

Barbara Unger has shared about the new regulatory expectations regarding GMP Regulatory Intelligence.  Indeed, we have heard that FDA inspectors have started asking people about what processes they have in place to monitor new regulations, guidelines, and developments.  In part, this is why we offer the GMP Regulatory Intelligence newsletter.

Now, we go deep into a serious issue that has received a lot of attention and press – data integrity. I’d venture to guess that billions of market capital has been lost because of this one issue.  The crazy part is this – it’s not even close to being a new issue.  As you’ll see, the data integrity story began at least 15 years ago.  Continue reading

New Question FDA Inspectors May Ask You at Your Next Inspection

ARE YOU READY-I was intrigued by a recent conversation I had with Barbara Unger, the editor-in-chief for GMP Regulatory Intelligence.  It’s becoming increasingly clear that the FDA wants to make sure you have a rigorous process to stay updated about the latest regulations and guidelines.  Here’s what she had to say: 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

How the FDA has changed, How the 483 has changed, & how we should use 483s to get smarter

Barbara UngerBarbara Unger, new editor-in-chief of GMP Regulatory Intelligence, has been providing some great insights on this blog. Last week, she shared her perspective about key FDA enforcement trends. Yesterday, she gave us some insights on her previous roles.

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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

What FDA enforcement trends do you see in your industry?

Barbara UngerThis week, I got a chance to ask our new editor-in-chief of GMP Regulatory Intelligence a few questions. Her responses were so thorough and insightful that we decided to publish her responses in as a series. Today is part I, where we asked her: “What FDA enforcement trends do you see in your industry?” Continue reading

Is the FDA ORA reading room bookmarked on your browser? Get GMP Regulatory Intelligence

 

  • Is part of your job to prep your company for FDA inspections?
  • Do you spend part of your week culling through various FDA, EMA, ICH, PIC/S and EMA-related websites tracking down changes in regulations, guidelines, and concept papers?
  • Is the FDA ORA reading room bookmarked on your browser?

Continue reading

New FDA 483 Subscription Service Available

Get all the 483s you need. FDAzilla now offers an FDA 483s SUBSCRIPTION SERVICE where you can access all of our 483s any time you want throughout the calendar year. We have one of the most comprehensive libraries of 483s, with 3,500+ 483s that is updated quarterly (We anticipate bringing in at least 1,000 more in the next 12 months).

LEARN MORE>>

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

How Does the Government Shutdown Impact FDA Inspections?

Half Open, Half Closed

The government is still shut down, though the FDA is still about half-open.  The question is: which half?

The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off. Continue reading

FDAzilla mentioned on front-page WSJ story

 

FDAzilla was mentioned in a front-page story today in the Wall Street Journal.  The article mirrors a key theme that we’ve talked about here – that the investment community is becoming more and more interested in FDA 483s, FDA inspections, and other government data.

Current and potential investors of your company may actually be reading your FDA 483.

Read the whole article here>> Continue reading

Ranbaxy gets hit by FDA again

Ranbaxy stock took a 30% hit today following an import alert issued by the FDA. The alert was reportedly issued based on serious cGMP issues at the Mohali plant from September and December 2012 483s.  Ranbaxy’s other two plants in India were already barred from importing to the U.S., this third plant in India was supposed to be the model plant, paving the way to a recovery. Obviously, this is a huge blow to the company.

For more context on Ranbaxy’s tumultuous year, read FiercePharmaManufacturing’s write-up.  FDAzilla has the September 2012 FDA 483 available for immediate purchase and download in the FDAzilla store.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.