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ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
M00002158
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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
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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