颗粒剂生产工艺规程.pdfVIP

制药有限公司

颗粒剂工艺规程

颁发单位：GMP办公室

工艺规程批准程序

文件名称颗粒剂生产工艺规程

规程起草单位起草人签名起草日期

规程审核单位审核人签名审核日期

规程批准批准人签名批准日期

执行日期

变更记录

变更原因

修订号

批准日期

执行日期

分发部门综合办公室、质量管理部、生产部

目录

1、剂型及规格···················································3

2、处方和依据···················································3

3、生产过程质控要点·············································3

4、生产的工艺流程图·············································4

5、操作过程及工艺条件···········································5

6、工艺过程中所需SOP名称及要求·································8

7、工艺卫生及环境卫生···········································8

8、工艺验证及具体要求···········································9

9、设备一览表及主要设备生产能力·································9

10、物料平衡及经济技术指标计算···································9

11、技术安全及劳动保护···········································10

12、劳动组织与岗位定员············································11

．剂型及规格

剂型：颗粒剂。

2．处方和依据

2005版《中华人民共和国兽药典》第一部；2003版《兽药质量标准》。

3．生产过程质控要点：

工序质控要点质控目标频次

配料称量品种、规格、数量与指令一致1次/批

投料品种、数量品种、规格、数量与指令一致1次/批

混合

搅拌时间、均匀度符合标准要求每批

手提成团，搓之即

制软材符合标准要求每批

散。

制粒粒度粒度均匀每批

干燥失重、温度、

烘干符合标准要求每批

时间

整粒粒度符合标准要求每批

总混含量均匀度含量均