Laws, Regulations, Guidance, and Concept Papers:
- FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011.
- EMA published 1 on IMPs for consultation.
- HPRA, WHO, Health Canada, and CDSCO each published 1.
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Among the non-guidance publications this week:
- The MHRA inspectorate blog provides examples of data integrity failures in the GDP area. It includes a nice section on spreadsheets which is also applicable across all GXP areas.
- FDA and EMA also published a handful in this area.
- FDA posted 3 warning letters to drug firms this week and 1 to a compounding pharmacy.
- We also have a collection of Class II and III drug recalls and a handful of import alerts.
- Europe published 1 report of GMP non-compliance.
- Pfizer entered into a corporate integrity agreement, along with their extensive monetary fine.
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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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