GMP Regulatory Newsletter: Summary Scan | Week of 4/8/18

Laws, Regulations, Guidance, and Concept Papers

A bit of a busier week than last week for guidance:

  • The FDA published 6 documents.
  • Nothing from EMA in the areas we follow.
  • WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance.

Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA and PMDA.

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


Enforcement is still a bit light:

  • 1 warning letter to a drug firm
  • 1 to a compounding pharmacy

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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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