GMP Regulatory Newsletter: Summary Scan | Week of 3/25/18

Laws, Regulations, Guidance, and Concept Papers

A slow week for guidance publication:  2 from FDA and 1 from WHO. The non-guidance area saw the usual collection from EMA, MHRA, FDA and 1 each from MHRA and TGA.

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


Enforcement included:

  • 2 warning letters to drug manufacturers
  • 2 warning letters to compounding pharmacies
  • FDA released 2 form 483s issued to sites in India

We see the usual collection of drug recalls and import alerts. For auditors, Rx-360 just published an Audit Manual for Data Integrity. It is free to all, membership in the organization is not required.

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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