GMP Regulatory Newsletter: Summary Scan | Week of 7/29/18

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GMP Regulatory Newsletter: Summary Scan | Week of 7/29/18

Laws, Regulations, Guidance, and Concept Papers

  • Another collection of FDA User Fee Rates for FY2019 was released (including those for drugs, outsourcing facilities, and biosimilars).
  • EMA published several items including a broad draft guideline that covers gene therapy products and the CAR-T family of products.
  • WHO published 3 guidance for consultation.
  • HPRA, Health Canada, and PIC/S each published 1 item.

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

GMP News Flash Sale


  • Picked up this week with 5 warning letters:
    • 1 device
    • 1 compounding pharmacy
    • 3 pharma firms
  • We continue to provide the FDA requested information in our summaries (free consulting for anyone who has similar problems).
  • Several import alerts were put in place for failure to follow drug GMPs, including for one of Hospira’s sites in India with exceptions for ‘necessary’ medicines.

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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