GMP Regulatory Newsletter: Summary Scan | Week of 5/6/18

Laws, Regulations, Guidance, and Concept Papers

A collection of both draft and final guidance:

  • The FDA and EMA published this week
  • Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read!

Also, the non-guidance publications continue:

  • MHRA, EMA, and FDA published
  • Among this later collection are the MHRA GCP Inspection Metrics
  • Changes in the FDA IOM 2018 (regarding electronic records and cosmetics)
  • Additional item in the EMA Q&A for GMPs

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


Enforcement was light again this week:

  • 1 drug manufacturer receiving a warning letter
  • 2 new drug firms forms-483 released by FDA
  • Several forms-483 issued to compounding pharmacies
  • A small handful of recalls
  • 1 lone import alert for the week
  • 2 pending consent decree agreements with stem cell clinics — supporting FDA’s focus on tightly regulating this area

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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