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

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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 - Change Management System as a Key Element of a Pharmaceutical Quality System

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ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5

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ISPE Good Practice Guide: Interactive Response Technology

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Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011

Description

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.