| Name | Support | Language | Availability | Edition date | Price | ||
|---|---|---|---|---|---|---|---|
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PDF sécurisé |
English |
Active |
1/1/2013 |
€423.00 |
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Details
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 strategies
Packaging and labeling approaches
Storage and distribution recommendations
Regulations categorized by region/country
Approaches to management of drug accountability, traceability, complaints and recalls with reference to the original sourcing strategy
Regulatory differences between NIMPs and comparators
Additional Info
| Author | International Society for Pharmaceutical Engineering |
|---|---|
| Published by | ISPE |
| Document type | Guide |
| Theme | /subgroups/36300 |
| EAN ISBN | 9781936379576 |
| Number of pages | 56 |
| Keyword | ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) |
