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

jan 2013 Publisert

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Merknad: Denne standarden har en ny utgave: ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

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Omfang

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

Dokumentinformasjon

Standard fra ISPE
Publisert: 1. januar 2013
Versjon: 0
Varetype: IS
ISBN:

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Version history Historikk (45)

ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

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ISPE ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

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ISPE ISPE Good Practice Guide: Good Engineering Practice, Second Edition

ISPE ISPE Good Practice Guide: Maintenance

ISPE ISPE Good Practice Guide: Equipment Reliability

ISPE ISPE Good Practice Guide: Critical Utilities GMP Compliance

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ISPE ISPE Good Practice Guide: Asset Management

ISPE ISPE Good Practice Guide: Process Validation

ISPE ISPE Good Practice Guide: Single-Use Technology

ISPE ISPE Good Practice Guide: Technology Transfer

ISPE ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

ISPE ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases

ISPE ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

ISPE ISPE Good Practice Guide: Management Engineering Standards

ISPE ISPE Good Practice Guide: Operations Management

ISPE ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems

ISPE ISPE Good Practice Guide: Technology Transfer

ISPE ISPE Good Practice Guide: Clinical Supply Systems

ISPE ISPE Good Practice Guide: Booklet Labels