ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2013

Full Description

Recent survey results show that the pharmaceutical companies often take an overly conservative approach to NIMPs (or Non-IMPs) due to regulatory and operational ambiguity. This can lead to unnecessary expenses and process steps, which can needlessly complicate clinical trials.

The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) aims to provide practical operational guidance and drive a consistent industry approach to the use of NIMPs. The Guide contains criteria for classifying NIMPs and an overview of current NIMP regulatory requirements.

This in-depth Guide will help you properly manage NIMPs by providing guidance on:Sourcing strategiesPackaging and labeling approachesStorage and distribution recommendationsRegulations categorized by region/countryApproaches to management of drug accountability, traceability, complaints and recalls with reference to the original sourcing strategyRegulatory differences between NIMPs and comparators

Product Details

Published: 01/01/2013 ISBN(s): 9781936379576 Number of Pages: 56 File Size: 1 file , 2.1 MB