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iSPE GPG: Controlled Temp Chambers (2nd Ed) Download - USD
iSPE GPG: Controlled Temp Chambers (2nd Ed) Download - USD
Good Practice Guide: Controlled Temperature Chambers 2nd Edition
Discounted member price: 295.00
595.00
You could save 50.4%

With the increasing complexity of global distribution for medicines requiring controlled temperatures, the ISPE Good Practice Guide: Controlled Temperature Chamber - Commissioning and Qualification, Mapping and Monitoring (Second Edition) provides guidance on the lifecycle management of GMP-controlled temperature chambers from creating a user requirements document to decommissioning a unit. The controlled temperature chambers discussed in this Guide range from purchased commercial off-the-shelf items such as freezers and refrigerated delivery vehicles, to walk-in cold rooms and walk-in freezers, to custom-built units such as warehouses. The risk-based approaches covered include commissioning, temperature mapping, and periodic review, along with examples and sample templates. The Guide has been revised to align with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), presenting a cost-effective way of demonstrating and maintaining compliance.

Member Price: $ 295.00
Non Member Price: $ 595.00
Item #: IGPGCTC2DLUS

ISBN: 978-1-946964-51-9
Author: ISPE
Publisher: ISPE
Format: Download
Pages: 134
Publishing Date: 12/21