Over the years, the Redica blog (formerly Govzilla) has published over 725 articles covering a breadth of topics including:

And, more.

To serve as a resource for you and your company and to help orient you to the scope of the Govzilla blog, we assembled a list of some of our most useful, relevant, and popular articles of all time.

  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 Ultimate Guide To Form FDA 483s: Go beyond the basics of the Form FDA 483 and learn all you need to know.
  3. 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?
  4. FDA: How Pharma Companies Are Unknowingly Introducing Risk Into Their Quality Management Systems: Consumer Safety Officer Emilie Kahn shares her take on the increased risk that companies are unknowingly introducing into their quality risk management (QRM) systems.
  5. FDA Cites Part 11 In Clinical Trial – We all “know” FDA doesn’t cite Part 11 in 483s, right?  Well, maybe.
  6. 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.
  7. 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!
  8. 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.
  9. 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.
  10. 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.
  11. 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”.
  12. 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.
  13. Repeat Deficiencies In Lupin Limited Warning Letters: Lupin Limited (India) came up short on both taking a global view to remediation as well as addressing issues at all sites.
  14. Identification Of Software Validation Shortcomings: Why doesn’t FDA commonly cite ‘lack of software validation’ as a deficiency” to drug manufacturers? 
  15. How To Talk So That FDA Will Listen, And How To Listen When They Talk: Advice That Could Be Worth Millions: Having a strong data package including extensive product and process knowledge is critical to getting a new drug approved, but by itself may not be enough. 
  16. COVID-19 Pandemic And Your GMP Audit Schedule For 2020: Bottom line, supply chain issues will be with us in unexpected ways during this public health crisis. Take a look at the GMP audit program and some options that may be able to help mitigate risk in this area.
  17. Overview: 2018 MHRA GMP Inspection Deficiencies: This article provides a high-level overview of the 2018 data, and we will do a later follow-up report including additional granularity and trends over the past few years.
  18. CDER Warning Letter Trends By Facility Type: Recently, the CDER warning letter issuance skyrocketed from 70 in FY2014 to 128 in FY2018, an increase of 83%. What types of firms are taking the heat? And where are they located?
  19. FDA Expanding Its Sterile Drug NIPP Inspection Pilot To Include Other Dosage Forms: Alonza Cruse explains that the pilot phase for NIPP for inspections of sterile drug products has concluded, and FDA will be using the model for inspections of other drug product types.
  20. Deep Pockets | Does The FDA Get Tougher If The Owner Gets Richer?: We provide five recent examples where the FDA appears to increase their enforcement intensity when an acquiring firm with perceived ‘deep-pockets’ enters the game.

Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

June 29, 1:30 p.m. EST

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

Panel Discussion – Remote Audits

Panel Discussion opt in image

Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

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Prepare for your next inspection.

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Prepare for your next inspection.

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Get help choosing the right CRO.

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Compare two companies of your choice.

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Download the Special Report

Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
Redica Systems Enforcement Analytics

Prepare for inspections of Clinical Investigator sites.

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Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

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SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

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Prepare for your next inspection.

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Monitor compliance at your Clinical Investigator sites.

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Keep up with the latest Regulatory Developments on Clinical Trials

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Save your team valuable time when using External Monitoring.

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Save time and Resources when using External Monitoring.

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Get immediate access to the news that matters to your sites.

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See how we can help you eliminate yet another spreadsheet.

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Stay ahead of changing regulations.

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Upgrade your CDMO management strategy.

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Compare the enforcement history of your CDMOs.

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Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Sign up for your FREE account today and get instant access to Enforcement Analytics.

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Upgrade your inspection strategy.

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Upgrade your inspection strategy.

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INDEX INFORMATION  Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

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Evaluate Your CDMOs

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Compare the inspection history of your CDMO sites.

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