This document addresses the specification and demonstration of capability and system reliability to successfully deliver a medicinal product as part of design verification and manufacture, utilizing empirical methods as well as modelling. This includes risk-based techniques to establish and demonstrate the required reliability level for all disposable single use drug delivery systems (DDSs) for which there is a single opportunity to deliver a single dose of a medicinal product.

Product Details

Published:

11/17/2025

ISBN(s):

9780539260298

Number of Pages:

24

File Size:

1 file , 2 Bytes

Product Code(s):

30469896, 30469896, 30469896

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus