AAMI TIR48:2015

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Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
standard by Association for the Advancement of Medical Instrumentation, 08/14/2015

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1.1 Inclusions

This Technical Information Report (TIR) provides recommendations on the application ofCGMPs for drugs, devices, biologics, and human cells, tissues, and cellular and tissuebased products during development and marketing of combination products (drugdevice,biologic-device, drug-biologic, or drug-device-biologic), in accordance with theFDA's final rule (21 CFR Part 4; 78 FR 4307, 2013—hereafter “The Rule” or “FDA's FinalRule”). These recommendations are intended to inform the adoption and application ofCGMPs for combination products.

1.2 Exclusions

The TIR does not address topics outside the realm of CGMPs. Additionally, the TIR mayinform practices for combination products marketed outside the United States, but it isnot intended, or considered to address non-U.S. requirements comprehensively.

Product Details

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1 file , 330 KB