Laws, Regulations, Guidance, and Concept Papers:
- Lots of PIC/S guidance this week along with a couple from the FDA and EMA and 1 each from MHRA and HPRA.
- FDA’s withdrawal of a draft biosimilar guidance is in response to industry concerns about the bar that was set in establishing biosimilarity over time. It will be interesting to see the revised draft guidance when it publishes.
- The non-guidance area had the usual collection from FDA, MHRA, EMA, TGA, HPRA, and ICH.
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- 1 GLP warning letter that includes an interesting reason why the warning letter recipient did not need SOPs
- 1 more OTC warning letter
- 1 issued to a compounding pharmacy
- Europe published 1 report of GMP non-compliance
- The usual collection of drug recalls
- 1 import alert in the areas we follow
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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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