从GMP发展方向，谈设计，质量体系，信息化管理，与计算机验证

Jason

请有需要的药厂参加在江苏泰州医药城的有价值的cGMP质量体系研讨会，

研讨会主题：从GMP发展方向，谈设计，质量体系，信息化管理，与计算机验证
研讨会日期：2013年11月6日

研讨会讲题：
上午：
1. 09:00-10:00，讲题：风险管理在设计项目上应用，演讲人：丁之洁，福斯特惠勒工程设计（河北）有限公司首席工程师，， 注册化工工程师，高级工程师 华东理工大学GMP研究中心兼职研究员，中国医药设备工程协会专家委员会高级专家。
2. 10:00-11:00，讲题：GEP的基本理念以及在医药工程项目管理中的应用 -中国电子系统工程第四建设有限公司，演讲人：马骏，中国电子系统工程第四建设有限公司副总裁，高级工程师，中国医药设备工程协会副会长，中国医药工程环境专业委员会主任委员，中国医药GMP验证专业委员会(筹）负责人，上海市室内环境净化协会副会长，2010版GMP实施指南编委，国家洁净室施工验收规范编委，国际制药工业协会（ISPE）会员
3. 11:00-12:00，讲题：GMP质量体系的建立，演讲人：刘哲生，洛施德企业管理咨询 (上海) 有限公司GMP资深顾问
下午：
4. 13:00-14:00，讲题：如何透过信息化手段提升质量管理效率，演讲人：许哲毓，洛施德企业管理咨询 (上海) 有限公司执行总监
5. 14:00-15:00，讲题：计算机验证培训，演讲人：许哲毓，洛施德企业管理咨询 (上海) 有限公司执行总监

联络：司信喜
企业服务中心  副主任
泰州医药高新技术产业园区管委会（中国医药城）
地址：江苏泰州药城大道1号
电话：0523-86200087；15850859976
邮件：xinxi_si@126.com

syhorchid

中国GMP将走向何方

Jason

将与国际欧美的GMP接轨，具体时间没人知道，尤其是电子计算机验证。

Jason

制药行业的信息化项目不纯粹是 IT 项目，而是 GMP 咨询项目:
软件只是管理工具，软件内配置的流程是否符合GMP法规的要求，才是制药行业实施信息化的重点。借由信息化项目来优化SOP流程，可以提高GMP管理水平，同时更合规的来操作GMP流程，收到一石二鸟的功效.

Jason

Jason Liou (刘哲生）is Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, CFDA, TFDA, EU, etc.)

Expert is a professional to the pharmaceutical and biotechnology industries. His background includes 20 years with Pfizer and Abbott in a variety of positions. In his last assignment at Pfizer, he was manager in pilot Plant/Manufacturing responsible for introduction of new products (both final dose form and the bulk pharmaceutical chemical). This responsibility included technology, manufacturing business planning, and project management. Other responsibilities included technical troubleshooting for Antiviral API & final dose form at contract plants, chemical manufacturing, and central project engineering.

Expert is knowledgeable and up-to-date in current Good Manufacturing Practices (cGMPs), especially as applied to bulk pharmaceutical chemicals,oral (sustained release) and Sterile process drug products. As a Quality Director in Kanion Pharmaceuticals , Expert led the assessment of bulk raw materials and drug substance suppliers from cGMP, business, management, environmental, and technology perspectives. Quality management of products included capsules,t ablets, coated and uncoated, injectable drugs made by both aseptic process and terminal sterilization, and lyophilized products. Expert can answer detailed questions concerning pharmaceutical products and product development, and parenteral product processing.

Expert also started-up the chemical development function in Egretpharma (Shanghai) This included initiating cGMPs for a contract facility and new group. As a quality manager at Norvartis (Shanghai), he has made several audits of bulk manufacturers, primarily cGMP related.

As Senior Director of CMC in Egretpharma, Expert was responsible for the pilot product troubleshooting (process and analytical methods) and transfer of new products from R&D to pilot plant/manufacturing. Expert has written and reviewed Chemistry, Manufacturing, and Controls (CMC) sections for INDs, ANDAs, and DMFs covering both bulk drug an d final drug products.

Throughout Expert's industrial career (>24 years), all his positions have been involved in process research and development, manufacturing, technology transfer from development to manufacturing and quality management. All these positions involved interfacing between R&D, and Pilot Plant/manufacturing. His skills have been honed in process and product development, transfer of technology, strategic long range focus in planning and facilities, up-to-date knowledge of pharmaceuticals cGMPs (especially as applies to bulk drugs and injected drug product), and management of contract development and manufacturing firms.

Jason

　　许哲毓，洛施德企业咨询管理上海有限公司总经理，兼任中电洛施德制药咨询上海有限公司 (中国电子系统工程第四建设有限公司之控股公司)总经理。负责多个cGMP咨询项目，客户包括：齐鲁集团，扬子江制药，山东绿叶，山东威高，沈阳兴齐等。
　　职业经历：
　　洛施德企业管理咨询有限公司(新加坡 /中国上海)
　　►负责东南亚及中国台湾地区业务
　　►负责多个cGMP咨询，差异分析，质量体系建设，与整厂验证项目
　　►多次协助客户通过 FDA/EMEA cGMP 认证
　　►客户包括 Lonza, Pfizer, GSK, Bilcare, Roche等
　　Pfizer (新加坡)
　　►负责质量保证工作
　　►负责 Computer System GMP Compliance 项目
　　SAP (USA)
　　►负责制药行业 SAP 系统实施，与计算机验证工作
　　►客户包括 Genentech, Baxter, B. Braun 等
　　Mr. Hsu has rich experiences in pharmaceutical industry, specializing in GMP consulting and Computer System Validation. Mr. Hsu is now working as general manager for CEFOC-Soltoris Management Consulting, a joint venture company of CEFOC and Soltoris Singapore, to dedicate in providing EPCMV and cGMP consulting service to help China pharmaceutical companies meet higher GMP regulation requirements. Mr. Hsu also has in depth knowledge and experiences in applying information technology in pharmaceutical industry, to help client not only increase productivity, but build up a robust IT system to maintain and improve GMP environment.
　　Prior to CEFOC-Soltoris, Mr. Hsu has worked for Soltoris Singapore, Pfizer, and SAP in areas of quality assurance, GMP compliance and pharma IT solution.

Jason

制药行业有着独特的GMP法规要求，GMP所强调的良好生产规范，从法规而言，各国均有厚厚一叠的条文规范，其内容涵盖制药企业主要的业务范畴，包括生产管理，设施与设备管理，包装与标签管理，物料管理，实验室管理，与质量管理。但从最基本的理念而言，GMP真正希望企业达到的，是下面的目标：
“企业应建立完善GMP体系，以确保能重复，持续，稳定的生产符合质量要求的药品”

Jason

计算机验证的关键在于风险评估
”FDA has placed increased emphasis on risk management throughout all aspects of the quality management system (QMS). This is what all foreign pharmaceutical and auditors are currently looking at.”
风险评估是目前所有检察官和跨国药厂最高度重视的工作之一，并且检察官期望制药企业能够在各方面都确实落实的GMP要素。风险评估不只是多做几份SOP或撰写几份文件。大部分人会误解成只有偏差管理，CAPA，变更控制等流程才会用到风险评估。
风险评估也应该要被落实到验证的流程中，不管是计算机验证或是其他的验证
验证不应只是我们熟悉的模板化的 IQ, OQ, PQ 了