AAMI TIR48:2015(R2021)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
Hardcopy , PDF
05-02-2024
English
03-26-2021
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 (drug-device, biologic-device, drug-biologic, or drug-device-biologic), in accordance with the FDA’s final rule (21 CFR Part 4; 78 FR 4307, 2013—hereafter "The Rule" or "FDA's Final Rule").
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