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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The FDA Re-Org Has Begun. What Does it Mean for You?

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

BACKGROUND:

The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products.  Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.

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28 Unique Data Integrity Deficiencies That Aren’t Really Unique

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

We’ve all been following the health authority’s identified deficiencies in data governance and data integrity for the last few years, though this enforcement action has been ongoing for almost twenty years.  A comprehensive GMP Intelligence program follows 483s and warning letters for information on the FDA’s focus.  Particularly in this area, the best learning materials are often provided by the regulatory authorities like the FDA.  The early deficiencies in this area cited disagreement between data submitted to the FDA in a regulatory filing vs the original data identified at the site.  Most recently the use of ‘integration interruption’ capability of chromatography data systems has been identified as a means of data manipulation.  In addition, some firms have gone to extremes in physically blocking the FDA’s access to areas which they have a right to inspect.

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Is The FDA Changing Their Interpretation?

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

Why Didn’t the Internal GMP Audit Group Identify that Before the Health Authorities?

The FDA inspection observations continue to identify the shortcomings in many of the same areas over the last five or more years. That begs the question why.  Does the FDA rapidly shift its focus in that short a time period? Are they applying novel interpretations that the industry has not anticipated? Alternatively, is the internal GMP audit group focusing on the wrong areas?  Or is management downplaying the internal audit findings saying something along the lines of “The FDA has reviewed that program and not found any faults, so no, we’re not making any changes – particularly the costly ones.”  Let’s take a look at the various options.

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Our database now has 703,956 FDA inspections

Just a quick update – the FDAzilla Enforcement Analytics database was updated with data through April 25, 2017. We typically refresh the inspections data every 3 weeks or so, pair new warning letters with inspections every week, and add new 483s, EIRs, and 483 response letters every month.

As of now, our database has:

And the best part is that it’s all linked together.

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FDA Sent These 7 Warning Letters for Pharma Companies | April 2017

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “products being misbranded” to sites “not ensuring that test procedures are scientifically sound.”

From pharmaceuticals in India, Pennsylvania, and more, here they are (starting with the most recent):
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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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