Laws, Regulations, Guidance, and Concept Papers
A busy week on the guidance publication front for FDA, WHO, HPRA, and Health Canada. A busy weekend of reading material!
- Among the most important from the FDA is the 21-page item on alternative mechanisms for complying with the GMPs for combination products.
- The non-guidance area includes the usual collection from MHRA (including an inspectorate blog post), FDA, EMA, and HPRA.
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- Enforcement was light this week with only 1 FDA drug warning letter issued to an OTC firm in Taiwan.
- Europe posted 1 notice of GDP non-compliance.
- A handful of recalls and import alerts round out the area.
- There was also a recent form 483 issued to Glenmark Pharmaceuticals Ltd (India), a site that manufactures solid oral dosage forms.
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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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