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ISPE ISPE Good Practice Guide: Interactive Response Technology

nov 2011 Publisert

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The Guide provides guidance on how to: successfully implement an interactive response technology to manage key clinical trial activities, particularly expiry date management and program pooling; ensure robustness of the technology, contributing to its effectiveness and reliability; and communicate and foster a standardized, industry wide approach to critical functionality of Interactive Response Technology when used in managing investigational medicinal product.

Dokumentinformasjon

Standard fra ISPE
Publisert: 1. november 2011
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

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

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

ISPE ISPE Good Practice Guide: Quality Laboratory Facilities

ISPE ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems

ISPE ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities

ISPE ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

ISPE ISPE Good Practice Guide: Comparator Management

ISPE ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry