Category Archives: Drugs


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

China published their annual report of drug inspections for 2016 on June 2, 2017.  The 31-page document reports on a variety of inspection types including but not limited to: pre-approval inspections, GMP certification inspections, and GMP follow-up inspections.  The report is accompanied by tables and figures.  For the most part, it is easily understood, but where discrepancies seem to appear between the various values and terminology, I’ve highlighted the uncertainty.  Some types of inspections are absent here, but the report provides specific details on the inspections and the deficiencies identified.

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6 Key Take-Aways from the 2016 EMA Annual Report

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

The EMA published their Annual Report for 2016 in May 2017, and it provides highlights of their work in partnership with the national health authorities.  Christa Wirthumer-Hoche, chair of the EMA Management Board, provides the Forward to the report, and Guido Rasi, the EMA Executive Director, provides the Introduction.  The report identifies important activities in 2016 and how they advance public health.  It also holds a collection of graphics from a variety of areas including human and veterinary medicines, the European regulatory network, and inspections/compliance. The report also identifies 22 Annexes that may be found on the Agency’s website but are not included in the report.  

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When Will the FDA Move On from Data Integrity?

The FDA has been writing up companies on data integrity since the year 2000. Even after all the horror stories, and even after billions of dollars of market cap have been erased from it, here we are in 2017, still talking about it.

Here is some troubling text from recent Warning Letters that cite data integrity:

“…our investigator observed your warehouse supervisor tearing out pages from your firm’s annual report and placing the pages into his pocket.”

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Data Integrity cGMP FDA draft guidance

FDA Draft Guidance on Data Integrity and Compliance With CGMP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The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.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