AAMI TIR48 PDF

AAMI TIR48 – Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products

This Technical Information Report (TIR) provides information on how to effectively implement FDA’s regulation on Current Good Manufacturing Practices (CGMP) for combination products. Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another, and the FDA regulation became effective July 22, 2013 (21 CFR Part 4). The TIR, where appropriate, also considers best practices, guide-lines, and standards used both in the United States and other regions. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. It should be noted that, while the information contained in the TIR has been carefully considered, it is up to the individual manufacturer to ensure compliance with all regulatory requirements that apply to its products.