GMP Regulatory Newsletter: Summary Scan | Week of 5/27/18

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GMP Regulatory Newsletter: Summary Scan | Week of 5/27/18

By | 2018-06-06T16:45:54+00:00 June 6th, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers

This was a short week in the US with the Memorial Day holiday on Monday:

  • The FDA published 6 guidance documents
  • WHO published 1
  • EMA didn’t publish any in the areas we monitor
  • The non-guidance collection includes the usual from the FDA, EMA, MHRA, and HPRA this week
  • Among the more important announcements are the addition of 2 EU countries to the existing MRA between FDA/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:

  • FDA published 3 warning letters to drug firms, 2 of which are OTC manufacturers
    • This continues their heavy emphasis of the OTC market segment that started in 2017 (we will publish a special supplement on this topic in July)
  • Europe published 1 report of GDP non-compliance
  • FDA released what sounds like a very painful form 483 from their re-inspection of Zimmer-Biomet
  • FDA published drug recalls in all classes this week, more than a handful of recalls awaiting classification, and 1 import alert

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

Barbara W. Unger 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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