文件编码:公司企业标准******生产工艺规程(有限公司年月日颁布年月日执行生产工艺规程文件登记表文件名称生产工艺规程颁发日期年月日颁发部门GMP办生效日期年月日文件编号分发部门原规程号无版本号第版文件编制新订□修订复审□编制人审核人批准人编制依据国家食品药品监督管理局国家药品标准颁布件、GMP批准文号复制人复核人复制份目录一、产品概述.....................................................................................................................................1二、反应原理.....................................................................................................................................1三、工艺流程及环境区域划分示意图..............................................................................................2四、原料配比.....................................................................................................................................2五、工艺过程及工艺条件..................................................................................................................3六、技术安全及劳动保护..................................................................................................................4七、卫生条件.....................................................................................................................................4八、原辅料、成品的质量标准..........................................................................................................4九、岗位定员.....................................................................................................................................7十、设备一览表及主要用途..............................................................................................................7十一、原辅料消耗定额......................................................................................................................7十二、物料平衡.................................................................................................................................8十三、精制流程图.............................................................................................................................8十四、工艺规程变更登记表..............................................................................................................9十四、工艺规程变更登记表..............................................................................................................9生产工艺规程一、产品概述:1、品名:2、汉语拼音:******3、英文名******4、2、结构式、分子式、分子量:结构式:分子式:C24H30N2O8分子量:******化学名称:******性状:本品为白色或类白色片状结晶或结晶性粉末,无臭、味微涩。本品在水中微溶,在乙醇中极微溶解,在氯仿中几乎不溶。二、反应原理:HOCH=CH-COO-H+HNNHCH3OHOCH=CH-COO-H2+NN+H22CH3O2C10H10O4+C4H10N2→C24H30N2O83888647432kg7.1kg理论值重量(kg)=****易溶于乙醇,****易溶于乙醇,而生成的产品******极微溶于乙醇而析出结晶(成盐),得到较纯的******。2388重量(kg)×474乙醇************精品结晶分离干燥检验内包装贮存包装桶清洁清理内包装材料乙醇**粗品过滤图例:300000级区入库一般生产区过滤*****精品外包装三、工艺流程及环境区域划分示意图:四、原料配比:(W/W)品名规格重量比备注乙醇≥92%10kg配成乙醇溶液******含量≥98%1kg乙醇≥92%10kg配成乙醇溶液******含量≥96%1kg五、工艺过程及工艺条件:1、溶解工序:1.1按原料配比在乙醇计量罐中取320kg乙醇抽入溶解罐中,在称量室称取32kg*****投入溶解...