In this issue:
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ISPE offline COP in Suzhou- Member free
•
ISPE offline COP in Mudanjiang- Member free
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ISPE upcoming events
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Sep-Oct Member Gift Package is Available Now
•
2015-2016 ISPE China Board of Directors Election Ended Successfully
•
ISPE Volunteer Recruitment
•
ISPE Publications Recommendation
Events:
2014 ISPE Biologics Development Symposium-Register Now
Date: Nov 30-Dec 2, 2014
Venue: Zhuhai, China
Find the latest speakers list and program agenda on symposium website.
You’ll hear about the latest information of Generic Product Development & Quality, the guideline of mAb
biosimilars and Chinese Pharmacopoeia from regulatory officials and clinical trial designs and regulatory
guidelines and practices etc. Register by Oct 31 to have a 20% savings.
Speakers at a glance:
Zhinan Chen | Academician of National Academy of Engineering
Caroline Kuhn|Roche
Junzhi Wang | Deputy Director-General of NIFDC
Helen Hartman |Pfizer
Yong-jiang Hei| Executive Medical Director of Amgen China
Joe Zhou | CEO of Genor BioPharma
Don’t miss the opportunity to showcase your products and services at this influential event! Download the
Sponsorship plan
2014 ISPE China Training Course-HVAC
Date: Nov 13-14, 2014
Venue: Shanghai, China
Course introduction:
The course builds on a solid understanding of HVAC and contamination control principles to assure control of
critical environments. Participants will review global cGMP regulations, as well as common interpretations of
those regulations and how they may apply to their facilities.
The class will explore critical issues at each stage of the product lifecycle, from R&D to Manufacturing, such as:
controlling cross-contamination between products, determining the correct classification of spaces, proper
control of storage temperature and humidity, setting acceptance criteria for HVAC systems and using risk
assessment to set environmental criteria.
Target audience：
Project engineers, HVAC technicians and mechanics, HVAC control designers and commissioning personnel;
Professionals needing a thorough understanding of HVAC systems utilized in pharmaceutical operations
For more information about ISPE China Training, please visit training website.
2014 ISPE-CCFDIE China Conference is Coming this Oct
Date：Oct.28-30, 2014
Venue：SZCEC, Shenzhen, China
Keynote Session:
 Policy and Regulations
Conference Sessions:
 The safety of Biological products & The challenges of Monoclonal antibody research
 Optimization of process & Operational excellence
 The industry thinking of The new revised Drug GMP implementation
 Digital manufacturing & Factory construction
 SUS technology risk assessment and validation consideration in Biomanufacturing process
 The engineering system & CMO
CFDI of CFDA Session:

Challenges and development of drug inspection
Conference Agenda
Contact person: Mr. Zhu (TEL: 86-10-82212866-6018, Mobile: 13641206254, E-mail: zhufeng@ccfdie.org )
Visit the conference website for more information and online registration
2015 ISPE China Annual Spring Conference-Join us in Beijing
The long-anticipated ISPE China Annual Spring Conference 2015 will be held in Beijing on April 21-22, 2015. As
the most influential event in China Pharmaceutical industry, the conference is designed to cover all chain of
pharmacy focusing on fields of Regulatory, Quality and GMP; Facility and Engineering, Drug Product and
Manufacturing Process, Biological Drug Development and Manufacturing, and Investigational Product/Clinical
Supplies and meet the practical need of industry professionals.
ISPE China Annual Spring Conference 2014 Recap:
• 70+ Presidents, VPs, CEOs from the leading pharm companies brought the cutting-edge knowledge,
information and practical experience
• Senior regulatory officials from CFDA, US FDA and PIC/S shared their insights into the policy trends
• 5 tracks and 70+ hot topics covered the whole drug lifecycle
• 500 participants, 60% came from manufacturers and 40% were senior managements
Visit the conference website for more information about 2014 ISPE China Conference.
Membership Zone
ISPE offline COP in Suzhou- Member free
Date: 2pm-5pm, Friday, October 17
Venue: Crystal Pharmatech (B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park Suzhou, China)
Agenda:
 14：00-14：10 Welcome Speech- Crystal Pharmatech Co., Ltd.
 14：10-14：45 The Importance of Crystal Forms in Drug Development – Dr. Zhang Yanfeng, CTO,
Co-founder of Crystal Pharmatech Co., Ltd.
 14：45-15：20 Process Chemistry and Technology Development- Tang Wenjun, Research Professor,
Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences
 15：20-15：50 Networking
 15：50-17：00 Visit Crystal Lab and Biobay
Please email China@ispe.org with your name, company, ISPE member ID and mobile number for registration.
Please also indicate “Suzhou COP October” in the email title. If you have any questions please contact Helen
Jiang (021-2312 3640)
ISPE offline COP in Mudanjiang- Member free
Date: 12 am, Oct 24 – 3 pm, Oct 25
Venue: Mudanjiang OncoGenerix Ltd. (Hailin City, Mundanjing Urban District, Heilongjiang Providence)
This site will be completed and commissioned at the end of 2014, which will manufacture highly potent
chemotherapeutic products for cancer treatments that will meet CFDA, US FDA and EMA regulatory
requirements. With a capacity of 30 million vials per year the manufacturing facility will process 2mL to 100mL
vials within the following integrated unit operations:
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Equipment GMP cleaning & component preparation.
Formulation.
Vial washing, depyrogenation, filling, lyophilization & capping.
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Vial inspection, integrity testing, labeling & cartoning.
Equipment decontamination & GMP cleaning.
Please email China@ispe.org with your name, company, ISPE member ID and mobile number for registration.
Please also indicate “Mudanjiang COP October” in the email title. If you have any questions please contact
Helen Jiang (021-2312 3640)
Sep-Oct Member Gift Package is Available Now
As one of key membership benefits, Monthly gift includes the hot information, frontier technical articles and
industry reports around the globe. Meanwhile, ISPE China also provides ISPE members with a local monthly
gift including local valuable contents/knowledge. ISPE members are able to download this gift package at the
beginning of every month on ISPE China Official Website.
HQ’s monthly gift（These will be available to you by Oct 31, 2014)
 Validation and Data Integrity in eClinical Platforms

Establishing and Managing Processes Enabling Delivery and Returns of Investigational Medicinal
Products (IMPs) to Patients' Homes
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (5) (These will be available to you
by Nov 7, 2014 )

Falsified Medicines Directive & Changes to EU GMP Guidance

Pre-filled Syringe System Development at Eli Lilly and Company
Don’t miss your membership benefits.
ISPE Committees and Activities
2015-2016 ISPE China Board of Directors Election Ended Successfully
The election for 2015-2016 ISPE China Board of Directors was successfully closed on Aug 22. Congratulations to
all the elected members. View the Board of Directors List
The 2015-2016 ISPE China Board of Directors will be the strategic leader of the Society in next two years and
responsible for identifying educational products that will be of benefit to ISPE and to the industry in general,
promoting knowledge and best practice sharing, and facilitating the communication and mutual understanding
between industry and regulatory agencies. Let’s looking forward to their new ideas and contribution to the
Society!
Last but not least, we would like to express our sincere appreciation to all the members who cast their ballots.
Volunteers Zone
ISPE Volunteers recruitment
Volunteers always play a vital role in ISPE’s development. You can join ISPE committees, the task group, or
community discussion groups to be our volunteers, and share your knowledge, experience and perspectives
with others. (ISPE member only) ISPE is now recruiting the volunteers for ISPE pharmaceutical engineering
magazine articles’ translation. Volunteers should have relevant knowledge and background. If you want to join
us, please contact Viona: 021-2312-3521 or email china@ispe.org .
ISPE Publications Recommendation:
Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the
practical, "real world" information you need to help your company build on current best practices to meet and
exceed regulatory standards.
ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products
The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) provides a
scientific risk-based approach based on ICH Q9 to manage the risk of cross-contamination to maintain product
quality and operator safety. This allows the selection of the appropriate risk control strategies to be
implemented on a case-by-case basis to maintain patient safety and assure product quality.
GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized
Systems (Second Edition)
Updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry
developments, the ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory
Computerized Systems (Second Edition) contains steps that scientists, suppliers and others involved in
managing laboratory computerized system acquisition, implementation, and operations can use to verify
laboratory systems are fit for their intended use.
The Guide provides a practical, risk-based approach for evaluating these systems, thus eliminating trial and
error. By following the principles outlined in the Guide, companies can save time and money, improve
communication with external parties and achieve higher quality, better performing systems.
For more information about ISPE publications, please visit ISPE official website or contact 021- 2312 3640 /
china@ispe.org.