In this issue:
• 2015-2016 ISPE China Board of Directors Election
• ISPE Upcoming Events in Q4
• ISPE COP (Sep 5, Beijing) - Member free
• July-August Member Gift Package Is Available Now
• New Student Chapter’s establishment
• Volunteer Recruitment
• ISPE New Publications Schedule
2015-2016 ISPE China Board of Directors Election
The ISPE China Board of Directors 2015-2016 Election is under way and notification has been emailed to all
ISPE Members eligible to vote (Aug 11 and Aug 18). The email contains a URL to access the ballot, review the nomination materials, and to cast your vote online. Please cast your precious vote by August 22, 2014.
Last but not least, we also would like to express our sincere appreciation to 2013-2014 ISPE China Board of
Directors and all committee members for the valuable contribution and support of ISPE in the past two years!
ISPE COP (Sep 5, Beijing) - Member free
With the purpose of facilitating the communication among ISPE members, ISPE is committed to organizing a series of COPs around China. And now ISPE is organizing a facility tour to WuXi AppTec Biopharmaceuticals, the leading pharm company in China. We will visit the areas for buffer prep, medium prep, seed culture, bioreactor production, and automated filling.
Date: Sep 5, 1:30 pm-4 am
Venue: 88 Meiliang Road. W, MaShan, Binhu District, Wuxi
Please email China@ispe.org
with your name, company, ISPE member ID and mobile No. Please also indicate
“Wuxi COP Sep 5” in the email subject. If you have any questions please contact Helen Jiang (021-2312 3640)

Jul-Aug member gift package is available now
HQ’s monthly gift （ It will be available by Aug 31, 2014)

Improving Access for Patients with Unmet Medical Needs – Overview and Best Practices for Success
 Update on ‘Office of Pharmaceutical Quality’—What’s New in CDER and How Does That Affect Your
Process?
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (4)
（ It will be available by Sep 7, 2014 )

Quality control of polysaccharide-protein conjugate vaccine and its process

QbD Strategy for mAb Biosimilar Development
Notice: Don’t miss your membership benefits .
ISPE China Facility Award 2014
To encourage design, engineering and operation personnel of pharmaceutical facility, improve design and operation of pharmaceutical facility in China, promote innovation and development of pharmaceutical facility in China, ISPE China would carry out China Facility Award.
Read more
2014 ISPE Biologics Development Symposium (Nov 30 – Dec 2, Zhuhai)
This symposium will devote two days to discuss:
 The guideline of mAb biosimilars and Chinese Pharmacopoeia

Key technical challenges for biosimilar and novel biologics development in China

Clinical and regulatory considerations, and case studies for biosimilar development
Highlights:

Meet with senior CFDA regulators during pre-conference workshop to learn and discuss the current status on biosimilar guidelines
 Learn from the Chinese Academicians about the latest market trends and biologics development status


Hear the latest technologies in novel biologics development, regulatory guidelines, quality control and practices from world-class scientists.

Learn from multinational pharms about the leading experience and case studies in clinical development.

Network with 200+ pharm professionals to exchange ideas and develop the business.
Register by Aug 31 st
to receive a 50% savings! Visit symposium website
2014 ISPE China Training (Aug 19-22, Shanghai)
Training Course:

HVAC for Pharmaceutical Facilities(November) Instructor: Yixin Yang
Nearly two hundred professionals attended the course “OSD”,” Basic Principles of Computerized Systems
Compliance Using GAMP® 5” and “Auditing for GMP” etc. The students were deeply engaged into the content and discussion, and had a fantastic experience in instructors’ knowledge, practices and views.
For more information about ISPE China Training, please visit training website .
ISPE China Annual Autumn Conference (Oct 28-30, Shenzhen)
The 2014 ISPE China Annual Autumn Conference, co-organized by CCFDIE, CCD and ISPE, will be held in
Shenzhen this Oct 28-30.
Focus on ISPE China Annual Autumn Conference:

Authoritative Organizers -Co-organized by CCFDIE, CCD and ISPE

Officially recognized by CFDA - Officers of GMP certification Institutions from all provinces will attend this conference

Variety of presentations - international GMP policies and regulations workshop; Six technical subforum; At least two same period seminars; Drug GMP from official view

The largest pharmaceutical engineering conference in CHINA- More than 600 people attended 2012
&2013 ISPE China Annual Autumn Conference
Visit conference website for more information.
Contact person: Mr. Zhu, TEL ： 86-10-82212866-6018, E-mail ： zf@ccpie.org

2014 ISPE Annual Meeting (Oct 12-15, Las Vegas)
The 2014 ISPE Annual Meeting will be held in Las Vegas, Nevada USA this October 12-15.To address the constantly evolving issues of the pharmaceutical industry, ISPE has created the comprehensive event to provide you with insights and proactive solutions.
Join us for ISPE’s premier annual event to hear the latest technical, regulatory and organizational directions and engage in learning, problem-solving and relationship building with colleagues from all sectors of the global pharmaceutical industry.
View more detailed information
New Student Chapter was established in July
ISPE student chapter of Beijing University of Chemical Technology was formally established in July. This is the fifth ISPE student chapter in China. Changyuan Yu, teacher of Beijing University of Chemical Technology was appointed as the academic advisor, and Peter Ma (Austar Group) was appointed as the industrial advisor. The specific information (including the contact info) will be published soon on www.ISPE.org.cn
.
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 new publications schedule in 2014 (released or will be released)
ISPE Good Practice Guides
• Clinical Supply Systems [to be Electronic-only]
• Technology Transfer (Second Edition)
• C&Q of Pharmaceutical Water and Steam Systems (Second Edition)
• Operations Management [may be Electronic-only]

• Sustainability [to be Electronic-only]
• Manual Sampling
• Disposables/Single USE Technologies
• Decommissioning of Pharmaceutical Equipment and Facilities
• Controlled Temperature Chamber (CTC) Mapping
GAMP® Guidance Series
• A Risked-Based Approach to Regulated Mobile Applications
ISPE Baseline Guides Series
• Science and Risked-Based Cleaning Process Development and Validation
• Oral Solid Dosage Forms (Third Edition)
Others
• GAMP Concept Paper: Data Integrity in eClinical Platforms
ISPE Baseline Guide: Sterile-Product Manufacturing Facilities (Second Edition)
The newly updated ISPE Baseline® Guide is a complete revision of the original version, and contains recommendations to help facilitate compliance with the latest FDA and EMA guidance. The update is aimed at a truly international audience, as it incorporates a comprehensive tabulation, explanation, and comparison of the cleanliness designations found in FDA, EMA, and ISO guidance documents, allowing for better harmonization in global facility design and a wider breadth of regulatory compliance internationally. The new
Guide consolidates all of ISPE's latest best practice recommendations on sterile manufacturing facility design into one document.
ISPE Baseline Series - Commissioning and Qualification
The Commissioning and Qualification Baseline® Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER).
For more information about ISPE publications, please visit ISPE official website or contact 021- 2312 3640 / china@ispe.org
.