Publication Date: September 2016
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This revised edition of 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. It considers fundamental concepts and policies for the control and management of pests in pharmaceutical manufacturing sites.
The Handbook is intended to assist organizations in following “Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (GMP Ordinance)” and “Application of PIC/s GMP Guide (Administrative notice regarding PIC/S GMP Guideline)” issued by MHLW and PMDA of Japan, which relate to the basic management of pharmaceutical manufacturing and associated quality management standards.
It 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.
The Handbook was created in the context of GMP best practices, and the original English translation was reviewed by the Guidance Document Committee. Consequently, its information is valuable for any facility using GMPs worldwide.
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