加拿大清洁验证指南（GUI-0028）

巴西木

------翻译人：Julia

原文官网地址： http://www.hc-sc.gc.ca/dhp-mps/consultation/compli-conform/2011-gui-0028_ltr-eng.php

加拿大清洁验证指南正在修订中，征求意见时间已关闭。期待新版公布中。以下是相关信息

Consultation: Cleaning Validation Guidance (GUI-0028)

加拿大清洁验证指南（GUI-0028）

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period. The new guides will be posted when the documents are finalized.

在线指南已关闭。本页显示内容为对指南在公示期间征求意见。指南新版本在定稿后将在公布。

Background 背景

The Cleaning Validation Guidance provides some guidance on issues and topics related to validation of equipment cleaning for the removal of contaminants associated with previous products, residues of cleaning agents as well as the control of potential microbial contaminants for pharmaceutical, biological and radiopharmaceutical products. Utilization of this information should facilitate compliance with Division 2 Part C of the Food and Drugs Regulations.

清洁验证指南所指供的指南涉及的是以下问题：药品、生物和辐射药品所用设备清洁以清除上一产品、清洁剂残留以及可能的微生物污染控制有关的问题。利用指南中的这些信息，可以有效符合食品药品法规C部分2章节的要求。

This guidance document was revised to reflect the current regulatory environment and to add an Appendix which provides concrete examples of cleaning calculations to establish maximum allowable carryover limits based on therapeutic dose.

本指南文件修订是为了反映现行法规环境，增加了一个附件，其中提供了根据治疗剂建立清洁后最大允许残留计算的具体实例。

The Good Manufacturing Practices (GMP) guidelines are available on Health Canada's Compliance and Enforcement website (www.health.gc.ca/gmp).

在加拿大卫生部GMP符合性和实施网站上可以找到GMP指南。

Information on the Document 文件中信息

The document under consultation, Cleaning Validation Guidance (GUI-0028), has been reviewed as part of the Inspectorate program's quality management process and has been amended. Highlights of the major changes to the document are as follows.

征求意见中的文件，清洁验证指南（GUI-0028），作为检查项目质量管理过程的一部分正在修订中，并增加了一些内容。以下是一些主要的变更：

―      The inclusion of a more detailed description of cleaning parameters.

―      包括了更具体的清洁参数

―      The update of the section outlining requirements for carryover of product residue.

―      更新了产品残留要求的纲要部分

―      The addition of an Appendix exemplifying the calculation of carryover limits.

―      增加了附件，给出残留限度计算的实例

―      Other administrative changes, including minor changes based on the Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001).

―      其它行政性变更，包括根据“优良生产规范（GMP）指南-2009版本，第二版（GUI-0001）”所做的小变更

syhorchid

谢谢分享

彩虹

学习了。。。。。。

咕咕

巴主，内容不全哦。

张正言

了解一下