MAXCONC

MBS

NOEL

Rinsing cycle 淋洗循环

SF

Srel

TDDnext

最大允许带入量：验证研究产品(“前产品，previous”)的可接受转移量。由一般限度ppm计算得出的。

General limit for maximum allowed concentration (kg/kg or ppm) of “previous” substance in the next batch.

“前”物质在后续批次中的最大允许浓度的一般限度(kg/kg或ppm)。

Minimum batch size for the next product(s) (where MACO can end up). 后续产品最小的批量(最大允许带入的结果)。

No Observable Effect Level 无明显影响水平。

Sometimes rinsing cycles/runs may follow the washing cycles. The rinsing cycles may be part of the routine cleaning procedure (e.g. to rinse out the washing solvent) or may be used for sampling purposes (e.g. rinsing with water after washing with detergents). Rinsing cycles that are not part of the routine cleaning procedure may be used for enhanced sampling during the cleaning validation exercise.

有时淋洗循环/运行可能在清洗循环后。淋洗循环可能是日常清洁程序的的一个部份(例如，淋洗掉清洗溶剂)，或在取样中使用(例如，在用洗涤剂清洗后用水淋洗)。淋洗循环不是日常清洁程序的一个部份，可以在清洁验证操作中加强取样。

Safety factor. 安全因子。

Relative standard deviation, coefficient of variation. 相对标准偏差，变异因数。

Standard therapeutic dose of the daily dose for the next product 后续产品的治疗每日药量。

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TDDpervious Standard therapeutic dose of the investigated product (in the same dosage form as TDDnext)

研究产品的标准治疗每日药量(与TDDnext相同剂型)

Washing cycle Usually the API equipment will be washed through with several portions

of solvent one after the other by the same repeated process. One cleaning process repetition with one of these portions is termed washing cycle (run).

通常原料药设备通过几种溶剂一个接一个地用相同的重复过程清洗。重复进行一个清洁过程称为清洗循环(运行)。

12.0 Copyright and Disclaimer

All documents and information contained in this guidance document are the property of the Active Pharmaceutical Ingredients Committee. Users of this document may use information contained therein only for personal use. No other use, including reproduction, retransmission or editing, may be made without the prior written permission of the Active Pharmaceutical Ingredients Committee*.

所有文件与本指南文件中信息是原料药委员会的财产。本文件用户可以作为个人使用在此的信息。在事前没有得到原料药委员会*的书面批准，不能用于其它，包括复制、转播或编辑的用途。

We have tried to make the information on or linked to this paper as accurate and useful as possible. However, we can take no responsibility for misinterpretations of the information contained in it.

我们设法将这些本文件信息或相关尽可能同样准确和有用。然而，我们不承担误解信息责任。

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