GMP Regulatory Newsletter: Summary Scan | Week of 7/22/18

Laws, Regulations, Guidance, and Concept Papers

  • This has been an unusually slow summer week
  • 5 documents published by FDA — 3 of which address user fees for FY2019 re: generic drugs, devices, and food re-inspections
  • 1 from EMA
  • 2 each from WHO and TGA
  • Non-guidance publications were issued by FDA, EMA, MHRA, ICH, and HPRA.

 

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Enforcement:

  • Very slow with 1 warning letter issued to a compounding pharmacy, that’s it for GMP drug warning letters
  • No device warning letters
  • Nothing from Europe this week
  • A few recalls and import alerts this week

 

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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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