xxx制剂车间清洁验证方案

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1、目录一、目的--------------------------------------------------------------------------------------------------------------------------2二、范围--------------------------------------------------------------------------------------------------------------------------2三、职责---------------------------------------

2、-----------------------------------------------------------------------------------2四、参考依据--------------------------------------------------------------------------------------------------------------------2五、内容----------------------------------------------------------------------------------------

3、----------------------------------31.清洁方法验证原理------------------------------------------------------------------------------------------------------32.设备描述------------------------------------------------------------------------------------------------------------------33.清洁方法描述----------------------

4、--------------------------------------------------------------------------------------34.最差条件确定------------------------------------------------------------------------------------------------------------44.1产品共用设备情况------------------------------------------------------------------------------------

5、-------------44.2参照产品的选择----------------------------------------------------------------------------------------------------44.3清洁间隔-------------------------------------------------------------------------------------------------------------55.清洗可接受标准的建立---------------------------------------------

6、--------------------------------------------------65.1残留量限度建立的原则------------------------------------------------------------------------------------------65.2可接受标准的确定------------------------------------------------------------------------------------------------66.取样方法和及取样计划------------------------

7、-----------------------------------------------------------------------77.相关方法及验收要求--------------------------------------------------------------------------------------------------98.清洁效果评价----------------