For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation — information you need to stay in compliance.

Each monthly issue brings you updates on the FDA’s approach to facility inspections, changes to the EU’s unannounced inspections and the latest on joint inspections in these and other jurisdictions and brings you the latest on:

  • Cybersecurity
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  • CAPAs
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Plus you’ll get links to Form 483s, warning letters, closeout letters, FDA policy notices and other reports to ensure your quality assurance efforts are a success.

Monthly, 12 issues/year. Electronic delivery.


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Key Benefits

LINKS TO KEY DOCUMENTS — You get links to documents that support GMP's articles, such as 483s, warning letters, closeout letters, guidances, FDA notices and many others.

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