求一份ASTM E3106-18 电子版

猫咪特工

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qianraybow1008

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陆本乐duj

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潇刺伦

学习了，，，，谢谢~！~！~！~！~

xcoss

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麦田.守望

stgz001 发表于 2019-3-11 11:57
以上的都不能复制，如有需要可以埃塔我，可以给我更换一些指南

Standard Guide for
Science-Based and Risk-Based Cleaning Process
Development and Validation1
This standard is issued under the fixed designation E3106; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide applies the life-cycle approach to cleaning
process validation, which includes the development,
qualification, and verification of cleaning processes. It is
applicable to pharmaceuticals (including active pharmaceutical
ingredients (APIs); dosage forms; and over-the-counter,
veterinary, biologics, and clinical supplies) and is also applicable to other health, cosmetics, and consumer products.
1.2 This guide is focused only on the cleaning of equipment
product contact surfaces and does not cover disinfection or
non-product contact surfaces (which are covered under other
existing guides: Ref (1),
2 USP <1072>, Guide E2614, and ISO
14698).
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
standard.
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.