Laws, Regulations, Guidance, and Concept Papers
FDA published four guidance documents this week:
- Two that address implementation of drug track and trace activities
- Two that focus more on medical and safety
The EMA published one item focused on inclusion of excipients in labeling. The non-guidance set of publications includes items from the EMA, FDA, MHRA, CDSCO, and TGA. Also published was a report from the Pew Charitable Trusts on drug compounding and the first OPQ Annual Report.
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Enforcement efforts published this week include:
- Three warning letters issued to pharmaceutical firms, all located outside the US.
- Two of the warning letters were issued to OTC manufacturers.
- FDA also published forms 483 from recent inspections of:
- Bayer AG (which resulted in a warning letter)
- Indoco Remedies Limited. Indoco received a warning letter for two plants in March 2017; this inspection covered a different plant.
Recalls this week included two Class IIs and two Class IIIs. The Class IIs both included dozens of products each from a compounding pharmacy and a re-packager. In addition, FDA issued a notification regarding products compounded and distributed by Cantrell Drug Company and also sought legal action to prevent the company from further producing and distributing drugs while simultaneously recalling products remaining in the marketplace. Finally, FDA published four Import Alerts. Europe did not publish any enforcement actions in the GMDP area.
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About the Author
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.
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