Category Archives: Drugs

Data Integrity cGMP FDA draft guidance

FDA Draft Guidance on Data Integrity and Compliance With CGMP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The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.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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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

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?

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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

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

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

Differences Between Medical Device and Pharmaceutical Clinical Trials – A Primer

Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting started in device development sometimes need clarification about the regulatory implications and practical differences between pharma clinical trials and medical device clinical trials. We’ve put together a basic primer to help guide readers through the most important steps along the medical device regulatory pathway to market, and to explain the disparities between it and the clinical trial process for drug approval. Continue reading

PDUFA Reauthorization: Major Upgrades for Orphan Drugs

Congress is to be congratulated on its progress toward passage of user fee reauthorization legislation. House and Senate-passed versions are being reconciled by staff, with a few fairly tough issues yet to be resolved. There is no apparent barrier to a final piece of legislation later this month or during July. Continue reading