Standard

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

Jan 2013 Published

Note: This standard has a new edition: ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

Singles purchase not accessible

This standard can not be purchased as a single sales.

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

Abstract

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

Document information

Standard from ISPE
Published: 1 January 2013
Version: 0
Document type: IS
ISBN:

Access to standards for the entire organization

Benefits of our business solution:

Contact us today for a non-binding offer

Singles purchase not accessible

Extended editions Extended editions (0)

Version history Related corrigendum and amendments (0)

Version history History (45)

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

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

ISPE ISPE Good Practice Guide: Validation 4.0

ISPE ISPE Good Practice Guide: Digital Validation

ISPE ISPE Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

ISPE ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems

ISPE ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) Second Edition

ISPE ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations

ISPE ISPE Good Practice Guide: Process Gases, Second Edition

ISPE ISPE Good Practice Guide: Containment for Potent Compounds

ISPE ISPE Good Practice Guide: Membrane-Based Water Injection Systems

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

ISPE ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification Mapping and Monitoring

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

ISPE ISPE Good Practice Guide: HVAC and Process Equipment Air Filters

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