[2021] Good Practice Guide：Controlled Temperature Chambers, Commissioning and Qualification, Mapping and Monitoring 2nd Edition

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英文名：Good Practice Guide：Controlled Temperature Chambers, Commissioning and Qualification, Mapping and Monitoring
出版社：International Society for Pharmaceutical Engineering (ISPE)
年份：2021
版本：2nd Edition
页码：134 页
ISBN：978-1-946964-51-9

The primary purpose of this revision was to align with the ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (Second Edition). Revising the Guide provided the opportunity to consider a periodic review frequency based on risk of failure to maintain uniform temperature and criticality of product stored rather than a standard, one-size-fits-all time span. In addition, the Guide was expanded to include ultra-low freezers, decommissioning a unit, and a discussion on using ocean reefers.


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