AAMI - TIR48
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
|Publication Date:||1 January 2015|
This Technical Information Report (TIR) provides recommendations on the application of CGMPs for drugs, devices, biologics, and human cells, tissues, and cellular and tissue based products during development and marketing of combination products (drugdevice, biologic-device, drug-biologic, or drug-device-biologic
The TIR does not address topics outside the realm of CGMPs. Additionally, the TIR may inform practices for combination products marketed outside the United States, but it is not intended, or considered to address non-U.S. requirements comprehensively.