丁勇:固体制剂国际化认证工作筹备经验分享

作者:本网编辑 文章来源:PHT《制药业》 点击数:64 发布时间:2017-06-13
丁勇,扬子江药业集团广州海瑞药业有限公司GMP质量办公室主任...
丁勇:固体制剂国际化认证工作筹备经验分享

丁勇

现就职于国内某大型合资企业,主要负责欧盟GMP认证相关工作。

Currently works in a large domestic joint company and mainly responsible for EU GMP certification related work.

有十年以上的制药工厂生产、质量管理相关岗位工作经验,熟悉口服固体制剂、无菌粉针剂、外用乳膏剂等制剂的现场质量控制。多次工厂建设项目经验,参与了固体制剂、冻干粉针剂等剂型的厂房设计、布局、验证、认证检查的全过程。

More than 10 years of working experiencerelated to pharmaceutical factory production and quality management, familiar with on-site quality control over preparations like oral solid preparations, sterile powder injection and external ointments etc. Involved in many plant construction projects; played a key role in thewhole processof plant design, layout, validation and certification for solid preparation and freeze-dried powder injection etc.

熟悉国内外GMP相关法律法规、行业指南,多次组织新工厂质量体系建设工作经验,从GMP文件、验证、变更、偏差、实验室管理等版块出发,设计建立可落地、可实施的质量体系。熟悉当前法规审计、认证检查方向,多次组织接待、陪同现场审计经验。

Familiar with relevant domestic and foreign GMP laws, regulations, guidelines;organizing quality system formulation; designed and developed pragmatic and applicable quality systems from GMP documentation, validation, changes, deviations and laboratory management etc. Expert in the current regulations audit and certification orientation; proficient in reception and companion of on-site audit.

对数据可靠性的管理、实践有较丰富的经验,多次主讲实验室数据可靠性检查、清洁验证、环境监测等板块课程,获得学员、主办单位较好评价。

Experienced in management and implementation of data integrity; lectured in courses like data integrity inspection, cleaning validation and environment monitoring etc. and received good comments from trainees and organizers.