Category Archives: quality assurance

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

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.

Continue reading

2,300+ FDA 483s now available in the FDAzilla store

By popular demand, we’re excited to announce that we have recently more than doubled the size of our 483 library. After painstakenly obtaining, organizing, renaming, and categorizing these documents, we now have 2,300+ 483s and counting in our library available in PDF format for immediate purchase and download. Continue reading

5 Ways to Prep for A Regulatory Audit: A Holistic Approach

Greg HattoyToday’s post is written by guest blogger Greg Hattoy.  Greg is a regulatory compliance specialist and insightful industry writer at his blog, greghattoy.com. Greg takes a distinct approach to regulatory issues and shares his innovative vision for the direction of the pharmaceutical industry

As a regulatory professional, lately it has becoming glaringly apparent that the only way to be successful in a regulatory audit is to take a holistic approach to quality. Holistic can be simply defined as ‘emphasizing the importance of the whole and the interdependence of its parts’. Like holistic medicine, for a ‘healthy’ status with the regulatory agencies, a company, with all their individual components, must be firing on all cylinders in regards to compliance with the greater goal of quality. Now I fully understand this may sound like hippie nonsense, but before the incense candles, spirit crystals, and kumbaya songs come out, let me further explain this thought. Continue reading

The Most Famous QA/RA Blogger Just Revealed His Identity

QAPharm_1

I started the QAPharm Blog three years ago as a creative outlet to share my perspective on the pharma industry and the quality assurance profession. I have appreciated my faithful readers from dozens of countries around the world.

For years, we’ve been following The QA Pharm Blog. Writen with an equal dose of deep industry expertise, refreshing transparency/voice, and wit, we’ve all wondered – who is this masked man? Continue reading

3 FDA 483 Stories in the Last 3 Weeks – Gilead, Alexion, and Novartis

Now I know why we’ve been getting more calls/emails from financial institutions and hedge funds inquiring about FDA 483s – more and more investors are being introduced to the term during investor calls. While technical in nature, digging through a company’s history of 483s – especially when compared to competitor company’s profiles – can uncover potential vulnerabilities in their manufacturing systems. Continue reading

FDA conducted 40,000+ inspections in 2012

Actually, 41,129 to be exact. That’s almost 5 inspections per hour for the entire year of 2012. Based on new data that we obtained from the FDA, here are some other interesting statistics:

  • 2 inspections in Bangladesh
  • 1 inspection in Botswana
  • 223 inspections in China  Continue reading

20 Resources to Ace Your Next FDA Inspection

20resourcesFDA inspections.  If you find yourself googling FDA inspector names, if you see your boss’s new Porsche parked in the parking lot with a license plate that says, “Zero 483s” (true story), then part of your job includes preparing your facility to be ready at any second for an FDA inspection.

This post is for you.  Here are our top 20 resources and FAQs for you:

FDA inspections 101

  1. What does the FDA inspect?  The FDA inspects all “manufacturers or processors” of FDA-regulated products – this includes these kind of manufacturers: vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, and animal processors.  The objective of these inspections are to ensure that they comply with all relevant regulations.
  2. What are the 3 types of FDA inspections. If you’re new at this, it’s important to understand the 3 basic reasons an FDA inspector is conducting the inspection. Continue reading

FDA inspector shows up. Have someone google him.

It’s Friday.  8:30am.  You’re looking forward to a long, nice weekend.  Then, you get a call from one of your associates.  An FDA inspector is waiting in the lobby.  She’s unannounced, she’s experienced, she’s eager, and she’s ready to go.

Do you know the feeling?  That feeling of that pop quiz in your least favorite subject in middle school.  times 1,000,000. Oh, man, not today. Continue reading

Drug Shortage: A Story of Self-Inflicted Management Tragedies

My blood boils when I read an article such as the one that appeared in the New York Times yesterday entitled Supply of a Cancer Drug May Run Out Within Weeks, by Gardiner Harris. This is one of many articles that has appeared lately about the mounting crisis of drug shortages across the country. This time it is the drug to treat acute lymphoblasic leukemia, which most often strikes children ages 2 to 5. Continue reading