GMP Regulatory Newsletter: Summary Scan | Week of 4/22/18

Guidance documents are available from the FDA and EMA this week across a variety of topics.  Lots to read there from both the FDA and EMA.

To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today.

Enforcement publications were busy this week:

  • 3 drug warning letters from FDA (2 were to OTC manufacturers)
  • 2 reports of EU GMP non-compliance
  • 2 forms 483 from sites in India

A collection of Class II and III recalls and a few import alerts (including one for refusal of an inspection).

For those who follow data integrity issues or audit in this area, we previously announced that Rx-360 published an Audit Manual for the topic.  It’s free to download.  There will be a webinar to address the content on May 14th 2018.  This is also free, register HERE.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at

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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence.  She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry.  At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers.  She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc.  This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends.  This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | | 805.217.9360

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