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[生产运营] ISPE虫兽控制的指南更新了

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药徒
发表于 2018-10-10 13:41:18 | 显示全部楼层 |阅读模式

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https://ispe.org/publications/guidance-documents/japan-affiliate-manual-pest-control
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药生
发表于 2018-10-10 13:56:50 | 显示全部楼层
The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in the previous ISPE Japan Affiliate Handbook on Pest Control (English Translation, version 4) and offers advice for new and aging GMP facilities. It proposes plans for incorporating pest control best practices into the project schedule for new construction, including advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas to inspect both during and at the end of construction.

With numerous examples of issues often found in older facilities, the Manual describes monitoring and inspection techniques, providing practical approaches for mitigation and remediation. In addition, it contains an extensive pictorial library of pests, including their ecology and environmental indicators, which will assist pharmaceutical manufacturing sites in their pest control monitoring program.

This Manual was edited by the ISPE Japan Affiliate Factory Auxiliary Issues Subcommittee in the Manufacturing Management Community of Practice (CoP) and reviewed by the ISPE Guidance Document Committee

Target building and facility areas covered in this Manual include:

Areas where raw materials and products are received, dispatched from, and stored
Areas where raw materials and products are inspected, weighed, processed, and packaged
Areas where specimens are stored and tested
Areas where personnel change clothes and take breaks
Outdoor areas adjacent to buildings where pharmaceuticals are handled
Machine rooms, water supply facilities, cafeterias, and other areas where waste is stored
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药生
发表于 2018-10-10 13:58:28 | 显示全部楼层
本帖最后由 meiya 于 2018-10-10 14:00 编辑

小册子的价格不低。Member Price $149.00 /
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药徒
 楼主| 发表于 2018-10-10 13:59:00 | 显示全部楼层
Publication Date: August 2018发布日期:2018年8月
Pages: 180
页数:180
TABLE OF CONTENTS目录

The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in the previous ISPE Japan Affiliate Handbook on Pest Control (English Translation, version 4) and offers advice for new and aging GMP facilities. It proposes plans for incorporating pest control best practices into the project schedule for new construction, including advice on integrating pest control requirements during all phases of construction, training construction staff, and determining areas to inspect both during and at the end of construction.

With numerous examples of issues often found in older facilities, the Manual describes monitoring and inspection techniques, providing practical approaches for mitigation and remediation. In addition, it contains an extensive pictorial library of pests, including their ecology and environmental indicators, which will assist pharmaceutical manufacturing sites in their pest control monitoring program.

This Manual was edited by the ISPE Japan Affiliate Factory Auxiliary Issues Subcommittee in the Manufacturing Management Community of Practice (CoP) and reviewed by the ISPE Guidance Document Committee

Target building and facility areas covered in this Manual include:

Areas where raw materials and products are received, dispatched from, and stored
Areas where raw materials and products are inspected, weighed, processed, and packaged
Areas where specimens are stored and tested
Areas where personnel change clothes and take breaks
Outdoor areas adjacent to buildings where pharmaceuticals are handled
Machine rooms, water supply facilities, cafeterias, and other areas where waste is stored

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请问,有电子版吗?  详情 回复 发表于 2019-5-17 08:54
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药徒
 楼主| 发表于 2018-10-10 14:00:55 | 显示全部楼层
meiya 发表于 2018-10-10 13:56
The ISPE Japan Affiliate Manual on Pest Control expands on the concepts and policies set forth in th ...

你就这么回复一下就有21朵花?怎么没人给我。。。

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一定是手抖了  详情 回复 发表于 2018-10-10 15:28
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药师
发表于 2018-10-10 14:51:16 | 显示全部楼层
有英文版吗?我可以帮忙翻译
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药生
发表于 2018-10-10 15:28:23 | 显示全部楼层
鲜橙汁 发表于 2018-10-10 14:00
你就这么回复一下就有21朵花?怎么没人给我。。。

一定是手抖了
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发表于 2018-10-10 15:46:50 | 显示全部楼层
这个东西有必要搞这么妖魔化吗,一般API厂虫鼠害很少。
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药徒
 楼主| 发表于 2018-10-10 16:51:51 | 显示全部楼层
hewe_cn 发表于 2018-10-10 15:46
这个东西有必要搞这么妖魔化吗,一般API厂虫鼠害很少。

首先虫鼠害少不一定哦,如果少也可能是控制的比较好;其次,不管有多少,有1个漏网之鱼都会产生很大的风险。
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药徒
 楼主| 发表于 2018-10-10 16:52:45 | 显示全部楼层

哦,累计的是吧
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药徒
 楼主| 发表于 2018-10-10 16:53:39 | 显示全部楼层
linbinbin 发表于 2018-10-10 14:51
有英文版吗?我可以帮忙翻译

林博,加个好友
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药徒
 楼主| 发表于 2018-10-10 16:54:45 | 显示全部楼层
hewe_cn 发表于 2018-10-10 15:46
这个东西有必要搞这么妖魔化吗,一般API厂虫鼠害很少。

首先虫鼠害少不一定哦,如果少也可能是控制的比较好;其次,不管有多少,有1个漏网之鱼都会产生很大的风险。
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药徒
发表于 2018-10-16 16:58:04 | 显示全部楼层
感谢分享
PS:这个在药厂好像不怎么受重视
我是指这本 指南
而非 虫害控制
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药徒
发表于 2019-5-17 08:54:33 | 显示全部楼层
鲜橙汁 发表于 2018-10-10 13:59
Publication Date: August 2018发布日期:2018年8月
Pages: 180
页数:180

请问,有电子版吗?
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发表于 2019-12-24 14:31:04 | 显示全部楼层
TABLE OF CONTENTS
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药神
发表于 2022-7-10 15:32:18 | 显示全部楼层
谢谢分享!!!
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药徒
发表于 2023-4-28 16:45:56 | 显示全部楼层
请问有电子版吗?求一个,谢谢!
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药徒
发表于 2024-9-3 14:07:05 | 显示全部楼层
这个还是非常重要的,每次审计几乎必看,必有缺陷
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药徒
发表于 2024-9-3 14:20:00 | 显示全部楼层
这个还是非常重要的,每次审计几乎必看,必有缺陷
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药徒
发表于 2024-9-6 15:43:27 | 显示全部楼层
谢谢楼主分享!
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