Author Archives: Barbara Unger

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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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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2016 MHRA GMP Inspections yields 50% more deficiencies in key areas

MHRA Identified GMP Inspection Deficiencies,  2016

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

The MHRA published a large slide deck that addressed GMP deficiencies identified during inspections in 2016.  They published a slide deck of similar information for 2015 a few months ago.  In this blog, we look at some of the similarities and differences between the two years. The data only represent deficiencies noted for dosage forms and do not include those identified at inspections of API manufacturers.  We previously compared the FDA inspection observations for 2016 with the 2015 MHRA Deficiencies.  

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Delay, Denial, or Limiting of Inspections Since 2008

Delay, Denial, or Limiting of Inspections Since 2008

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

In October 2014, the FDA published a final Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. Publishing this guidance was a requirement of section 707 of the Food and Drug Administration Safety and Innovation Act (FDASIA).  Section 707 of FDASIA adds 501(j) to the Food, Drug, and Cosmetic Act (FD&C Act) to deem a drug adulterated if it “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”  Before that time and since, the FDA cited instances where firms have delayed inspections or denied investigators access to areas or documents that they should be able to view.

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What is the Future of Outsourcing Facilities?

What is the Future of Outsourcing Facilities?

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

PART II Policies, Enforcement, and Predictions

Policies:
In this section, we will address policies and guidance that the FDA has published since the end of 2013, look at enforcement activities in this area, and make some predictions for the future of this market segment.

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