Changes in Regulatory and GMP Intelligence

Changes in Regulatory and GMP Intelligence

Surveillance, analysis and communication of regulatory and GMP intelligence has evolved over the past decade. The individual(s) tasked with this activity within pharma companies require broad experience in regulatory affairs and GMP compliance.  The individual(s) must have sufficient historical perspective to compare and contrast new requirements with those they replace and to compare requirements and expectations among the major health authorities. It is no longer sufficient to simply summarize new or revised requirements but rather it is necessary to provide the added value of determining how the new requirements may affect the firm’s operations.

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An Alternative to GMP Quality System Auditing in the Pharma Industry

An Alternative to GMP Quality System Auditing in the Pharma Industry

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

Executive Summary:

  • Historically, a quality systems approach to GMP auditing has become common practice. However, this systems approach does not routinely address the essential input into the system – the data.
  • Data integrity issues have drastically increased in the last year – and not just in foreign warning letters.
  • Why would you do business with a firm whose data you can’t trust?

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Warning Letters

FDA Sent These 7 Warning Letters for Pharma Companies | November 2016

We took a snapshot of the 7 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to maintain complete data to failing to prevent microbiological contamination.

From pharmaceuticals in Japan, New Jersey, and more, here they are (starting with the most recent):
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Warning Letters

FDA Sent These 6 Warning Letters for Pharma Companies | October 2016

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from allowing unauthorized access to confidential data to forgetting to put expiration dates on drugs.

From 3 pharmaceuticals in the USA and 3 abroad, here they are (starting with the most recent):
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Inspect your FDA Inspector Before Your Inspection

Today, I’m excited to officially announce a new set of services to help you prepare for your next FDA inspections – FDA Inspector Profiles.

We’ve taken 16+ years of FDA inspection data and combined it with other relevant databases to bring you a comprehensive, detailed look into any individual FDA Inspector. Continue reading

COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity

COMPARISION OF EMA and FDA Guidance on Data Management and Data Integrity

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

 

Major regulatory authorities published guidance addressing data management and data integrity in 2015 and 2016.  Two of the guidances, the draft from FDA published in April 2016 and the guidance from EMA posted in August 2016, take a Question and Answer approach.  The guidance from MHRA (HERE and HERE), PIC/S and WHO take the more standard narrative approach to regulatory guidance.  That having been said, all of the guidance documents are markedly similar in their overall expectations.  In this blog entry we look at the EMA and FDA Question & Answer guidances, the next entry will look at guidance from the other three authorities.

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Warning Letters

FDA Sent These 8 Warning Letters for Pharma Companies | September 2016

We took a snapshot of the 8 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from a product containing “hair and a black spider” to management failing to “document laboratory controls.”

From pharmaceuticals in Japan, Brazil, and more, here they are (starting with the most recent):
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October: FDA cGMP Quality News Briefing

What industry news have you been reading this month? At FDAzilla, we’ve compiled the most noteworthy articles we’ve come across in the weeks since our last update. This month’s picks include information from two conferences, surprising warning letters abroad and in the US, an explanation QSIT protocol, and stories of both exemplary and reprehensible strategies from companies dealing with in-house deficiencies. Take a look:

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INTERVAL BETWEEN INSPECTION and WARNING LETTERS STARTS to DECREASE

INTERVAL BETWEEN INSPECTION and WARNING LETTERS STARTS to DECREASE

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

 

A blog entry that evaluated FDA enforcement actions in the first half of FY2016 provided data to demonstrated that the interval between GMP drug inspections and warning letters almost doubled since FY2013.  The relevant table and graph is provided below.

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Warning Letters

FDA Sent These 13 Warning Letters for Pharma Companies | August 2016

We took a snapshot of the 13 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to “maintain written records” to failing to wear “clothing appropriate to protect drug product.”

From pharmaceuticals in Brazil, India, China, and 6 US states, here they are (starting with the most recent):
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