2013(第五届)弗戈制药工程国际论坛讨论热点

★无菌及生物制剂分会场

■ 无菌项目建设及管理案例解析;

■ 生物制剂车间布局与工艺设计;

■ 空调净化系统设计及验证方案;

■ 环境控制要点与技术手段;

■ 无菌工艺验证体系;

■ 生产质量风险管理和控制;

■ 先进隔离技术的应用;

■ 除菌过滤器灭菌及完整性检测;

■ 一次性使用技术的应用。

★ 固体制剂分会场

■ 固体制剂生产线GMP认证经验分享;

■ 流化床技术在固体制剂生产中的应用;

■ 成功的粉体工程案例介绍;

■ 原料药车间工艺布局与设计探讨;

■ 原料药洁净区的设计;

■ 固体制剂车间空气净化系统验证方案;

■ 固体制剂生产质量风险评估体系探讨;

■ 设备清洗及验证。

★ 信息化和自动化分会场

■ 药品生产过程中的环境温湿度监测自动化技术

■ 药厂计算机系统验证;

■ 优秀自动化制造规范GAMP 5的解读与应用;

■ 大型自动化控制系统在医药产品生产企业中的应用;

■ 无线技术在医药产品生产企业中的应用;

■ 跨国药企信息化建设经验分享;

■ 医药企业MES系统的开发与应用;

★ 中药制剂分会场

■ 中药行业趋势动向及规范化实施;

■ 不同中药剂型实施GMP认证的要点;

■ 中药制剂质量控制标准化研究;

■ 中药注射剂的质量风险与控制;

■ 中药制剂制备工艺现代化研究;

■ 中药新型给药系统研究技术与方法;

■ 中药国际化成功经验分享。

★ Sterile and biological preparation sub-forum

■ Analysis of cases of sterile project construction and management;

■ Layout and process design of biological preparation workshop;

■ Air-conditioning purification system design and validation solution;

■ Key points and technical means of environmental control;

■ Sterile process validation system;

■ Production quality risk management and control;

■ Applications of advanced isolation technique;

■ Sterilization filter’s sterilization and integrity testing;

■ Applications of disposable use technology

★ Solid preparation sub-forum

■ Sharing of experience in GMP certification of solid preparation production line;

■ Applications of fluidized bed technology in solid preparation production;

■ Introduction to successful cases of powder engineering;

■ Exploration of active pharmaceutical ingredient workshop process layout and design;

■ Design of clean area for active pharmaceutical ingredients;

■ Validation solution for air purification system of solid preparation workshop;

■ Exploration of quality risk assessment system for solid preparation production;

■ Equipment cleaning and validation

★ Informatization and automation sub-forum

■ Ambient temperature and humidity monitoring automation technology in pharmaceutical production;

■ Validation of computer system for pharmaceutical factory;

■ Discussion and applications of Good Automated Manufacturing Practice (GAMP 5);

■ Applications of large-scale automation control system in pharmaceutical manufacturers;

■ Applications of wireless technologies in pharmaceutical manufacturers;

■ Sharing of experience in information-based development of multinational pharmaceutical manufacturers;

■ Development and applications of MES in pharmaceutical manufacturers;

★ Chinese materia medica preparation sub-forum

■ Trends and standardized implementation in the traditional Chinese medicine industry;

■ Key points of GMP certification in different preparation formulations of traditional

Chinese medicines;

■ Research on standardization of Chinese materia medica preparation quality control;

■ Quality risks and control of traditional Chinese medicine injections;

■ Research on modernization of Chinese materia medica preparation process;

■ Research techniques and methods concerning new delivery system for traditional Chinese medicines;

■ Sharing of successful experience in internationalization of traditional Chinese medicines