AAMI TIR48:2015(R2021)
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
26-03-2021
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").
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.