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内蒙古
师范大学学报
Edition 2 (English Translation)
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ISPE Japan Affiliate: Pest Control Handbook © Copyright ISPE 2010
Disclaimer: All the contents of this Pest Control Handbook prepared by the ISPE Pest Control Handbook Working Group,
including the revised editions, do not constitute legal obligations such as GMP guidelines. The contents are made
原子核物理学up of general information on pest control activities, designed to strengthen initiatives for protecting pharmaceutical products from contamination by insects and rodents.
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, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or宝马案
consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability
whatsoever, arising out of or in connection with the use of this information.
© Copyright ISPE 2010. All rights reserved.
No part of this document may be reproduced or copied in any form or by any means – graphic, electronic, or
mechanical, including photocopying, taping, or information storage and retrieval systems – without written permission of ISPE.
All trademarks used are acknowledged.
ISPE Japan Affiliate: Pest Control Handbook
Edition 2 (English Translation)
Edited by Pest Control Handbook Working Group, Factory Issues Subcommittee Manufacturing Management Community of Practice (COP), ISPE Japan Affiliate
ISPE Japan Affiliate Office
Ishijima Bldg.7F, 1-11-10 Yushima
Bunkyo-ku, Tokyo 113-0034, Japan
Tel: +81-(0)3-3818-6737, Fax: +81-(0)3-3818-0575 jp
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Page 3Pest Control Handbook © Copyright ISPE 2010
Acknowledgments
The ISPE Pest Control Handbook was edited by the Factory Auxiliary Issues Subcommittee in the Manufacturing Management Community of Practice (COP) of the ISPE Japan Affiliate. This Pest Control Handbook was edited by gathering together the knowledge and experience gained from the
outcomes achieved by each of the working group members who have conducted pest control works at their facilities.
First Edition: 1 August 2010
机械效率教学
设计Second Edition: 1 October 2010
Edited by: Working Group of Pest Control Handbook, Factory Issues Subcommittee, Manufacturing Management COP , ISPE
Japan Affiliate
Editors (Japanese alphabetical order):
Fumio Adachi (Novartis Pharma K. K.)
Akihiro Okabe (Bayer Yakuhin, Ltd.)
Masaki Kato (Taisho Pharmaceutical Co., Ltd.)
Kiyoshi Kashimura (GlaxoSmithKline K. K.)
Yutaka Kobayashi (Nippon Shinyaku Co., Ltd.)
Makoto Takao (MSD K. K.)
Toshiyuki Takahashi (Mitsubishi Tanabe Pharma Factory Ltd.)
Makoto Takeda (Nippon Shinyaku Co., Ltd.)
Katsuhiko Hashido (Taiyo Yakuhin Co., Ltd.)
Taka-aki Maeda (Bushu Pharmaceuticals, Ltd.)
Tadahiko Masuda (MSD Co., Ltd.)
Goichi Yokoyama (Sanofi-Aventis K. K.) It is the sincere wish of the ISPE Japan Affiliate and all involved in the compilation of this handbook that it will be read
by many people in pharmaceutical companies and the pharmaceutical industry. We hope that by doing so they can
improve their knowledge and awareness on pest control management.
In addition, in compiling this handbook, we offer our gratitude to the people who gave us citations and references, as
well as all the people in related companies who are making efforts in pest control on a daily basis with the editors.
We the member of Working Group or the authors are grateful for Mr. T. Tani (C&S Co. Ltd.) of his supportive advices
for compilation of this Handbook. We also appreciate Jiho Inc. that allowed us to quote valuable articles edited in their journal Pharm Tech Japan .
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Page 4
ISPE Japan Affiliate: Pest Control Handbook © Copyright ISPE 2010
Table of Contents
1
Introduction ...........................................................................................................................5 1.1 Sc虹膜识别系统
ope ...........................................................................................................................................................5 2 Key Concepts ........................................................................................................................6 2.1
The Objectives of Pest Control ....................................................................................................................6 2.2
PDCA Cycles in Pest Control .......................................................................................................................6 2.3 Definitions . (7)
3 Pest Control Governance Organization (8)
3.1 Governance Organization and Control Manager .........................................................................................8 3.2 Supplier Services .. (8)
4 Monitoring (10)
4.1 Basic Policy for Monitoring (10)
4.2 Insect Monitoring Process (10)
4.3 Types of Insect Monitoring (12)
4.4 Methods of Periodic Insect Monitoring (13)
4.5 Methods for Managing Insect Monitoring Results (Evaluation and Analysis/Policies on Indicators) (15)
4.6 Methods for Evaluating Insect Monitoring Results (17)
4.7 Making the Most of Insect Monitoring Results, and Measures to be Taken when Control Criteria
are Exceeded (18)
4.8 Types of Rodent Monitoring (20)
4.9 Methods for Managing Rodent Monitoring Results ....................................................................................21 4.10 Measures for Rodents (Corrective Action (CA)).. (21)
5 Pest Control (22)
5.1 Basic Policy for Pest Control (22)
5.2 Environmental Pest Control (22)
5.3 Physical Pest Control .................................................................................................................................25 5.4 Chemical Pest Control . (29)
6 Inspections (Self-Inspections and Self-Audits) (31)
6.1 Basic Policy (31)
兽药
管理条例6.2 Self-Inspections (Physical Aspects) (31)6.3 Self-Audits (Procedural Aspects) ...............................................................................................................32 6.4 Recording Inspection Results (Records of Self-Inspections and Audits) (32)
7 Training (33)
7.1 Objectives of Training (33)
7.2 33 7.3 Ad-Hoc Training .. (34)
8 Citations and References ...................................................................................................35 9 Glossary (36)
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Page 5Pest Control Handbook © Copyright ISPE 20101 Introduction
The ISPE Pest Control Handbook considers fundamental concepts and policies for the control and management of pests (“pest control”) in pharmaceutical manufacturing sites.
This Handbook is intended to assist organizations in satisfying Good Manufacturing Practice (GMP) regulatory
expectations, which relate to the basic management of pharmaceutical manufacturing and associated quality
management standards.
This Handbook does not stipulate regulations on control criteria for pest control. In cases where alternative methods
are deemed appropriate based on rational evidence those methods may be employed.1.1
Scope This Handbook applies to pest control in pharmaceutical manufacturing sites.
1.1.1
Target Areas (Buildings and Facilities)
1. Areas where raw materials and products are received, dispatched from, and stored
2. Areas where raw materials and products are inspected, weighed, processed, and packaged
3. Areas where specimens are stored and tested
4. Areas where personnel change clothes and take breaks
5. Outdoor areas adjacent to buildings or places where pharmaceuticals are handled (the periphery of buildings and
green zones adjacent to the periphery)
6. Areas where waste, etc., is temporarily stored such as machine rooms, water supply facilities, canteens, and
peripheral areas 1.1.2
Intended Audience
This Handbook is recommended for:
1. Pest control officers and advisors
2. Personnel involved in processes ranging from receiving raw materials through to shipping products
3. Personnel involved in the management of buildings and facilities
This Handbook may also be used during introductory training on pest control for personnel involved in:
• production of pharmaceuticals
• facility management • personnel that plan to begin such work
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