GMP Regulatory Newsletter: Summary Scan | Week of 6/3/18

Laws, Regulations, Guidance, and Concept Papers:

  • A handful of guidance documents published this week from the FDA, EMA, and ICH.
  • The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives.

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

Enforcement:

  • 3 drug warning letters
  • A handful of recalls
  • 2 consent decree agreements
  • A few import alerts
  • Nothing this week in the enforcement area from Europe
  • One form 483 addressed poor management of complaints, including those which resulted in death

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 sales@fdazilla.com.

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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. | www.ungerconsulting.net | 805.217.9360

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