FDAzilla’s Top 20 Posts of All Time

Over the years, the FDAzilla blog has published over 650 articles.  We’ve acquired many readers since we started writing here in 2010.  With these newer followers in mind, FDAzilla has assembled a list of some of our most useful articles.  To put together this collection, we considered which posts have been the most searched-for and viewed over time, and evaluated these popular posts for helpfulness and continued relevance.

We hope this compilation will serve as a resource for you and your company.  It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.

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  1. Part 1: The FDA And MHRA’s Most Recent Drug Inspection Observations – A comprehensive GMP Intelligence program includes monitoring of health authority enforcement actions.
  2. The New FDA GMP Inspection Model – This publication describes the roles and responsibilities for the types of human drug inspections, identifies which area within the FDA leads the inspection, how planning is accomplished, the conduct of the inspection, and the communication of results from the inspection.
  3. To Understand Data Integrity, Just Read These 6 FDA 483s –  Take a look at 6 483s associated with data integrity that had broad impact throughout the industry or resulted in serious enforcement actions, including consent decree agreements.
  4. Data Integrity Trends In 483s And Warning Letters: Part 1 – The FDA cited data integrity on 79% of drug Warning Letters over the last 5 years.  If you cannot trust the data of the process and its results, then can you really trust anything?
  5. FDA Cites Part 11 In Clinical Trial – We all “know” FDA doesn’t cite Part 11 in 483s, right?  Well, maybe.
  6. Data Integrity: The Whole Story – The FDA has a long history of issuing serious enforcement actions for data integrity violation.  Monitoring certain data can protect your company from financial and reputation-taxing consequences.
  7. Data Integrity Trends In 483s And Warning Letters: Part 2 – With our analysis and tagging methodologies, this post gets into the specifics of what the FDA is actually citing when it comes to data integrity.
  8. The Story Of 3 Consent Decrees – Here we address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies.
  9. The Ultimate Guide To Form FDA 483s – Go beyond the basics of the Form FDA 483 and learn all you need to know.
  10. The FDA Has Had a Busy 15 Years – Take a look at thorough FDA inspection statistics over the years 2000-2015.
  11. 28 Unique Data Integrity Deficiencies That Aren’t Really Unique – See specific data integrity citations from over the years that may not be as new as you think.
  12. Part 1 | 2015 Vs 2018 – MHRA Data Integrity Guidance – This post provides thorough coverage of the additions, revisions and deleted items in MHRA’s 2018 Data Integrity Guidance as compared to its 2015 publication.
  13. Part 2: Drug GMP Warning Letters Data Governance And Data Integrity – Interested to see data integrity citation statistics?  This article provides every CY2017 warning letter with data integrity citations and also looks at these citations going back to 2008.
  14. Top 10 Responsibilities Of The Pharma Quality Unit – We compiled this list from FDA regulations and guidance documents that define the job of the Quality Unit.  After all, the Quality Unit is the only job description that appears in the Code of Federal Regulations!
  15. 10 Ways For Small And Virtual Companies To Prepare For A GMP Inspection – Following are our 10 suggestions for these firms to ensure a successful inspection outcome when they have limited experience in this activity and limited resources.
  16. [INFOGRAPHIC] The FDA, Warning Letters, And What To Expect In 2018 –  What kind of inspection doubled from 2011-2014?  How much experience does the average FDA inspector have?  This infographic, the only one of its kind, compiles data to provide details on the last 15 years of FDA inspections.
  17. MHRA’s “Right Environment” – Former FDA Investigator Peter Baker explains his belief that Quality Culture and data integrity are intrinsically connected based on MHRA’s concept of “right environment”.
  18. Why Did McKesson Receive The First DSCSA Warning Letter? – First-of-a-kind enforcement actions are always of interest in terms of what they tell us about the FDA’s potential future enforcement in an area.
  19. The Ultimate Guide To Researching Your FDA Inspector – Are you fully inspection-ready without knowing anything about your inspector?  We walk through 8 steps to help you and your team prepare before your inspector arrives.
  20. 5 Features to Look For in an EIR – An EIR provides a wealth of information regarding the site, conduct, and outcome of an inspection.  It is particularly useful for firms to understand what areas the FDA focuses on and how the FDA reviews documents.

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