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.
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.”
New data synthesized by FDAzilla has revealed several dramatic shifts with FDA inspection and enforcement activity.
The FDA issued 15 pharma GMP-related warning letters to manufacturing sites in China in 2016 – a 5-fold increase from years prior. China averaged 2.7 Warning Letters per year from 2013 to 2015. This explosion was led mostly by infamous FDA investigator, Peter Baker, who performed 17 inspections in China in 2016, leading to 13 FDA Form 483s and 4 Warning Letters. Continue reading
“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”
I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world. While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483. And then what happens after that? Continue reading
The FR announced availability of the long awaited 10-page FDA draft Guidance on Data Integrity and Compliance with CGMP for comment.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.
CHICAGO, IL – May 14, 2015
Today, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity. For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked together, creating huge potential for industry insight.
“Smart data has arrived onto FDA inspections. We are proud to unveil Enforcement Analytics today, a much-needed innovation in the regulatory space for the thousands of professionals who work on keeping their manufacturing processes up to snuff for the FDA,” said Tony Chen, co-founder and CEO of FDAzilla. Continue reading
What do you think about this infographic? Have ideas for future infographics? Post a comment below or email email@example.com. Continue reading