cGMP北大培训教材.docx

Revised as of 23 November 2020
cGMP北大培训教材
Centre for Pharmaceutical Information and Engineering Research
n by circling it
R&D
Regulatory (industry or government)
NOTE: Don’t forget to check all areas in
which you have worked.
Robert Horan (before FDA) FDA Investigator Robert Horan
Employed in industrial chemistry
laboratory
Microbiologist in pathology departments
of two hospitals in New York City, USA
MS Microbiology; PhD Biochemistry
Doctoral studies in protein biochemistry
FDA experience 18 years Inspections Branch
Pharmaceutical Inspectorate (level III drug
certification – highest FDA certification)
Performance Auditor responsible for auditing
other investigators seeking certification
Conduct inspections of sterile & non-sterile
products (APIs, dosage forms) worldwide
Taught at St. John’s University, NY
Provide training to FDA investigators/analysts
1
北京大学
2008年 5月
Robert C. Horan, .
美国
FDA药品检查员
引言
学员的经验
这个培训课程的学员是哪些人 :
高层管理人士 (CEO, 工厂经理)
质量保证
质量控制
生产/ 操作
请回顾一下你曾经接触过的每一个领域
并且回答:
（你在这个领域）多于5年或少于5年
圈出你目前工作的领域
研发
法规 (工业界或者政府部门)
提示: 请不要忘记回顾你工作过的所有领
域.
Robert Horan ( FDA之前) FDA Robert Horan
进入 检查员
18年FDA 药品检查经验 曾服务于企业的化学实验室
作为微生物学家，曾经在美国纽约两家
医院的病理科工作
微生物学硕士; 生物化学博士
博士期间研究蛋白质生物化学
在纽约 St. John’s 大学教书
药品检查专家组 (III 级药品检查员证书–
FDA 最高等级证书)
执行审核员，负责审核其他申请证书的
检查员的资质
负责世界范围内无菌和非无菌产品
(APIs, 制剂)
为FDA检查员/分析人员提供培训
2
FDA Investigator Robert Horan
Biotechnology Specialist (since 1997);
now involved in the recent expansion of
biotech inspections (therapeutic protein
products move from CBER to CDER)
Serving on working group with FDA
headquarters personnel to write a specific guidance document (in progress)
Inspections Worldwide Purpose of this training is:
USA
Europe (Germany, France, Spain, Italy,
Austria, England, Switzerland)
Asia (China, India, Singapore, Japan,
South Korea)
Dosage forms (many sterile products)
APIs (non-sterile; sterile)