GMP Regulatory Newsletter: Summary Scan | Week of 4/15/18

Laws, Regulations, Guidance, and Concept Papers

FDA published several new guidance, both draft and final, this week:

  • 2 are administrative
  • 2 address quality
  • 1 addresses format for submission of vaccines data
  • Bonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7.

TGA published 2 relevant items. A fantastic collection this week of non-guidance publications:

  • An MHRA blog
  • APICs guideline for audit of starting materials
  • 2 periodic newsletters from the HPRA

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


Enforcement this week included:

  • Warning letters to 3 OTC manufacturers located outside the US
  • 2 warning letters to compounding pharmacies

Warning letters this week demonstrate the intense focus on OTC manufacturers that FDA began in CY2017. FDA has accelerated their focus in this calendar year with 14 of 33 drug GMP warning letters issued to OTC drug manufacturers.

This week had the usual collection of recalls and import alerts. Cantrell Drug Company entered into a consent decree agreement with the government. One report of GDP non-compliance was issued for a distribution site in the Czech Republic.

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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