GMP Regulatory Newsletter: Summary Scan | Week of 7/1/18

Laws, Regulations, Guidance, and Concept Papers

  • Just a few guidance documents and updates on non-guidance documents.

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 warning letters.
  • 1 warning letter in particular is a read for anyone interested in what FDA expects regarding identified errors in non-validated Excel spreadsheets.
  • A limited number of recalls and import alerts this week.
  • A slow summer with the US holiday in the middle likely contributed here.

 

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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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