GMP Regulatory Newsletter: Summary Scan | Week of 5/13/18

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GMP Regulatory Newsletter: Summary Scan | Week of 5/13/18

By |2018-05-24T11:57:49+00:00May 23rd, 2018|Biopharma / Pharma, CGMP, FDA Enforcement News, Medical Devices|

Laws, Regulations, Guidance, and Concept Papers

A lite week for new guidance publications:  2 each from FDA and EMA.

Among the non-guidance publications are 2 of particular interest:

  • 1st is a report of the drug approval times in the major health authority jurisdictions (including some nice graphs and figures) published by The Centre for Innovation in Regulatory Science.
  • The 2nd is an FDA report on difficulties in reporting done by IQVIA regarding distribution of some controlled substances.
  • Data integrity is important everywhere.
  • Others are from FDA, EMA, MHRA, and HPRA.

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


Enforcement saw only:

  • 2 warning letters to drug manufacturers this week out of a total of 4 that were posted.
  • 1 European report of non-compliance for GDP deficiencies was made available.
  • Recalls identified only 3 firms.
  • Kroger Specialty Pharmacies recalled a total of approximately 67 products this week.
  • 3 unclassified recalls were announced.
  • 2 import alerts in the categories we follow.

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

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. | | 805.217.9360

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