ISPE 设备可靠性 完整版Equipment reliability.pdf

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文档介绍

For individual use only. © Copyright ISPE 2020. All rights reserved. GOOD PRACTICE GUIDE: Equipment Reliability

Disclaimer:

This Good Practice Guide provides practical guidance to help pharmaceutical organizations apply and improve

reliability at all stages of the equipment lifecycle. This Guide is solely created and owned by ISPE. It is not a

regulation, standard or regulatory guideline document. ISPE cannot ensure and does not warrant that a system

managed in accordance with this Guide will be acceptable to regulatory authorities. Further, this Guide does not

replace the need for hiring professional engineers or technicians.

Limitation of Liability

In no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each of

them, or the authors, b

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