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焦灵利:药品生产工艺验证实施策略及常见缺陷

作者:本网编辑 文章来源:PHT《制药业》 点击数:115 发布时间:2017-06-13
焦灵利,江苏省食品药品监督管理局认证审评中心副主任...
焦灵利:药品生产工艺验证实施策略及常见缺陷

焦灵利,江苏省食品药品监督管理局认证审评中心副主任

焦灵利,1989年中国药科大学毕业,取得学士学位;2004-2007年南京中医药大学研究生班学习,取得中药学硕士学位。具有主任药师、执业药师、执业中药师资格。现任江苏省食品药品监督管理局认证审评中心副主任,分管药品GMP、GSP认证工作。担任中国药科大学校外硕士生导师、全国执业药师工作专家、江苏省药学会药事管理委员会成员、国际药品检查员、国家局GMP、GCP、GLP检查员。

1989至2003年在南京南大制药有限公司工作,先后从事无菌冻干制剂生产管理,药品研发、质量管理和GMP改造认证工作,历任车间主任、质保部部长、总经理助理等职,具有丰富的药厂管理经验。

2003年调任江苏省食品药品监督管理局认证审评中心副主任,先后分管医疗器械产品注册,药品GMP、GSP认证等工作,参加国家局国际检查员培训和境外检查工作,具有丰富的理论知识和检查经验。

 

Jiao Lingli, graduated from China Pharmaceutical University and obtained bachelor's degree in 1989; studied in graduate class in Nanjing University of Traditional Chinese Medicine and master’s degree in traditional Chinese pharmacology from 2004 to 2007; having qualifications of chief pharmacist, licensed pharmacist, licensed pharmacist of traditional Chinese medicine; currently Deputy Director of Center for Certification & Evaluation, Jiangsu Food and Drug Administration, responsible for drug GMP and GSP certification; extramural master's supervisor of China Pharmaceutical University, national licensed pharmacist work expert, member of Pharmacy Administration Committee under Jiangsu Pharmaceutical Association, international drug inspector, state bureau’s GMP, GCP, GLP inspector.

Worked in Nanjing Nanda Pharmaceutical Co., Ltd from 1989 to 2003, successively responsible for sterile freeze-dried preparation production management, drug research and development, quality management and GMP renovation certification, served as workshop manager, head of Quality Assurance Department, general manager assistant etc, with rich experience in pharmaceutical factory management.

Appointed as Deputy Director of Center for Certification & Evaluation, Jiangsu Food and Drug Administration in 2003, successively responsible for medical device product registration, drug GMP, GSP certification etc, participated in international inspector training and overseas inspection organized by state bureau, with extensive theoretical knowledge and inspection experience.