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ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
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Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 01/01/2013
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
Product Details
- Published:
- 01/01/2013
- ISBN(s):
- 9781936379576
- Number of Pages:
- 56
- File Size:
- 1 file , 2.1 MB
