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Jingdong book

药品GMP指南：口服固体制剂

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Books Medical Science Pharmacy

Jingdong book

药品GMP指南：口服固体制剂

Name: 药品GMP指南：口服固体制剂
Brand: Jingdong book
SKU: 3117020101
Price: 52.55 USD
Availability: OutOfStock

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Content Description

《药品GMP指南：口服固体制剂》是《药品GMP指南》之一，由国家食品药品监督管理局药品认证管理中心编写，紧扣《药品生产质量管理规范（2010年修订）》的要求，参照了国际药物工程协会（ISPE）《关于新建和改造口服固体制剂厂房的基准工程指南》（2009年11月，第二版），学习借鉴了欧盟、FDA、WHO等关于药品生产质量管理、GMP规范和相关指南的新理念，以实际达到“最大限度地降低药品生产过程中污染、交叉污染以及混淆、差错等风险”的药品GMP基本目标为前提，与国际接轨，拓宽企业国际化视野，促进我国由制药大国向制药强国的转变。基本内容包括质量风险管理，生产管理，常用设备，生产过程控制，物料管理，验证，产品防护，健康、安全和环境。可供药品生产企业及工程设计、设备制造、药品监管等单位的管理、技术、生产和检查人员参考使用。

Catalogue

1 前言
1.1 背景
1.1.1 指南说明
1.1.2 法规背景
1.1.3 技术背景
1.2 范围
1.3 框架

2 质量风险管理
2.1 质量风险管理的原则和工具
2.2 口服固体制剂的质量风险管理

3 生产管理
3.1 概述
3.2 产品实现要素
3.2.1 机构与人员
3.2.2 物料
3.2.3 厂房设施
3.2.4 设备
3.2.5 公用系统
3.3 关键控制项目
3.3.1 批次管理
3.3.2 清场管理

4 口服固体制剂常用设备
4.1 生产设备
4.1.1 设计和选型
4.1.2 设备的校验
4.1.3 设备的清洗
4.1.4 设备维护
4.1.5 设备使用和文件记录
4.2 口服固体制剂生产中用到的特殊设备
4.2.1 模具
4.2.2 筛网
4.2.3 滤袋
4.3 中间体检测过程中使用的设备
4.3.1 紫外分光光度计
4.3.2 溶出试验仪
4.3.3 液相色谱仪
4.3.4 智能崩解仪
4.3.5 片剂硬度测试仪
4.3.6 酸度计
4.3.7 电子天平
4.3.8 电导率仪
4.3.9 卤素水分测定仪
4.3.10 金属检测器

5 生产过程控制
5.1 工艺设计
5.1.1 工艺设计的总体考虑
5.1.2 原料性质
5.1.3 技术转移
5.2 过程单元
5.2.1 过程单元的操作概述
5.2.2 配料
5.2.3 粉碎
5.2.4 混合
5.2.5 制粒
5.2.6 干燥
5.2.7 压片
5.2.8 包衣
5.2.9 胶囊制备
5.2.10 包装

6 物料管理
6.1 概述
6.1.1 质量标准和标识
6.1.2 供应商管理
6.1.3 物料和产品的接收
6.1.4 储存
6.2 生产过程中的物料管理
6.2.1 物料的储存管理
6.2.2 物料的分发与退库
6.2.3 物料输送
6.2.4 物料量的控制
6.3 检验与放行
6.3.1 原辅料与包装材料
6.3.2 中间产品和待包装产品
6.3.3 成品
6.4 产品销售与退货

7 验证
7.1 概述
7.2 工艺验证
7.3 清洁验证
7.4 包装验证

8 产品防护
8.1 概述
8.2 人员污染
8.3 厂房设施、设备污染
8.4 物料污染
8.5 工艺技术及环境污染

9 健康、安全和环境
9.1 非GMP风险的考虑
9.2 健康
9.2.1 员工健康危害的识别
9.2.2 员工健康危害的控制--隔离技术
9.2.3 员工健康危害的控制--密闭技术
9.2.4 管理控制和操作规程
9.2.5 个人保护设备
9.3 安全
9.4 环境
9.5 其他考虑
附录软胶囊的生产概述
词汇表
术语表
关键词表
参考文献

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