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沈菊平,GMP介绍及发展趋势

作者:本网编辑 文章来源:PHT《制药业》 点击数:632 发布时间:2017-06-13
沈菊平,南京圣和药业有限公司质量副总经理,沈菊平先生熟悉中国及国外主要GMP法规。
沈菊平,GMP介绍及发展趋势

沈菊平,南京圣和药业有限公司质量副总经理

 

沈菊平

南京圣和药业有限公司副总经理

熟悉中国及国外主要GMP法规。有丰富的中国 GMP、欧盟GMP和日本GMP等检查和认证的经验,并有许多成功案例。对药品的生产、质量、设备、验证和工艺有非常丰富的理论知识和实践经验,特别是无菌药品。丰富的项目管理经验,并有多次成功完成无菌药品项目的从项目设计、施工、 验收的经验,严格执行项目的安全、质量、进度和预算的管理。中国2010版GMP的主要起草者和修订者之一,为SFDA及各省市药监系统实施几十场的公开讲座和培训。配套GMP实施指南《无菌药品》的主要编委,同时协助修订《质量管理体系》、《公用工程及设施》指南。《药品注册批准前检查》专家审校成员、中国医药设备工程协会专家组成员、专家委员会主任、ISPE 会员。

04/2016~南京圣和药业有限公司副总经理;01/2016-03/2016卫材(辽宁)制药有限公司工厂长;04/2013-12/2015卫材(中国)药业有限公司高级项目总监;02/2012-03/2013江苏正大天晴药业有限公司集团质量总监;07/2007 – 01/2012苏州大冢制药有限公司品质管理部和研发部长;01/2006-06/2007广东大冢制药有限公司品质管理部部长;07/1991 – 12/2005华瑞制药有限公司研发副经理、项目验证经理、生产主管和值班经理。03/2003 – 03/2006东南大学工商管理硕士,09/1987 – 06/1991中国药科大学药学专业。

 

Shen Juping

Vice General Manager, Nanjing Sanhome Pharmaceutical Co., Ltd.

Master China and foreign GMP regulation. Rich experience of China GMP inspection, EU GMP and Japan GMP audit. Rich experience of aseptic process, equipments and quality assurance. Strong team building, team leading ability. Rich experience of project management, including project design, construction, inspection and audit. Control the project safety, quality, time schedule and budget strictly. One of the main authors and reviewers of China new GMP regulation. Being guest speaker for SFDA and provincial GMP and quality training. New GMP guideline 《sterile product》 , Deputy group leader, one of the main auditors for the guideline. 《 Pharmaceutical Pre-Approval Inspections》 experts audit member. Member of CPAPE experts group. Member of ISPE.

04/2016~ Vice General Manager, Nanjing Sanhome Pharmaceutical Co., Ltd.; 01/2016-03/2016 Eisai (Liaoning) Pharmaceutical Co., Ltd; 04/2013-12/2015 Senior Project Director, Eisai China Pharmaceutical Inc.; 02/2012-03/2013 Group Quality Director, Jiansu CHIA TIANQIAN pharmaceutical Co. Ltd.; 07/2007 – 01/2012 Director of Quality Management Department&R&D , Suzhou Otsuka Pharmaceutical Co. Ltd; 01/2006-06/2007 Director of Quality Management Department, Gudong Otsuka Pharmaceutical Co. Ltd; 07/1991 – 12/2005 Deputy manager of Development Dept \ Validation manager of phase II project \ Supervisor & shift manger in Production Dept, Sino-Swed Pharmaceutical Co. , Ltd.