Laws, Regulations, Guidance, and Concept Papers:
- A handful of guidance documents published this week from the FDA, EMA, and ICH.
- The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives.
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- 3 drug warning letters
- A handful of recalls
- 2 consent decree agreements
- A few import alerts
- Nothing this week in the enforcement area from Europe
- One form 483 addressed poor management of complaints, including those which resulted in death
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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.
Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360