GMP Regulatory Newsletter: Summary Scan | Week of 7/15/18

Laws, Regulations, Guidance, and Concept Papers

  • Among guidance documents this week are 5 from FDA
  • 4 from EMA
  • 1 each from Health Canada, HPRA, and IMDRF
  • 2 from EMA/EC address gene therapy
  • Non-guidance documents include the usual collection from MHRA, FDA, and EMA.
    • Included here are expansion and renewal of the EU and Japan Mutual Recognition Agreement and a Biosimilar action plan from FDA.


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



  • 2 drug GMP warning letters.
  • FDA also made available a 24-page form 483 issued to the Akorn Inc. site in Decatur, IL.
    • The primary focus of the observations is aseptic manufacturing of sterile products.
    • Several of the observations are noted to be repeats from previous inspections, never a good thing.
  • We have a few recalls this week including 24 kratom products with microbial contamination.
  • A few new import alerts were announced among the ones we follow.


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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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