GMP Regulatory Newsletter: Summary Scan | Week of 4/1/18

GMP Regulatory Newsletter: Summary Scan | Week of 4/1/18

Laws, Regulations, Guidance, and Concept Papers

It’s been a slow week all around, perhaps spring breaks and the holidays? Among the non-guidance publications, CFDA published an update on their 2017 Review Metrics.

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

Enforcement

A very slow enforcement week:

  • FDA published only 2 warning letters.
  • Nothing from Europe.
  • We do see the usual collection of drug recalls and a few import alerts that were imposed.

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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