Laws, Regulations, Guidance, and Concept Papers:
- Guidance documents this week were from the FDA, EMA, and HPRA.
- Among the FDA ones are 2 programs where FDA will further pursue and investigate criteria for their Quality metrics program.
- The non-guidance documents include publications from MHRA, EMA, FDA, TGAA, and ICH. Several are worth a serious read.
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- By and large an unusually sparse week for enforcement.
- Warning letter enforcement was light with just 1 warning letter to an API site in China where both deficiencies focused on data integrity failures.
- There were a few import alerts and recalls.
- Six GDP non-compliance reports associated with sites in Romania were published.
- Most interesting is the 32-page form 483 issued to the Mylan Pharmaceutical site in Morgantown, WV*.
- This is a must read, I would expect additional enforcement action of some sort.
Everyone have a happy and safe July 4th holiday!
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*Please note correction: a previous version of this post stated Morgantown, PA.
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.
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