In this issue:
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ISPE 2016 Upcoming Events
•
China ISPE Facility Award
•
2015 ISPE China Events Recap
•
Nov-Dec member gift package is available now
•
ISPE Volunteer Recruitment
•
ISPE Publications Recommendation
Events:
ISPE 2016 Upcoming Events
2016 ISPE China Annual Spring Conference (Apr 10-11, Shanghai)
Keynote Speech:
David Churchward, official from MHRA, will talk about Data Integrity in plenary session!
Breakout Tracks:
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Regulatory, Quality and Compliance
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Facility and Engineering
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Chemical Drug Product and Manufacturing Process
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Biological Drug Product Development and Manufacturing

Clinical Supplies
Register now and enjoy early bird! ISPE Member: RMB 2200
2016 Public Training (TBC)
2016 Workshop (TBC)
Global Events:
• Aseptic Processing Technology Conference (29 February - 1 March, VA, USA)
• 2016 European Annual Conference (7-9 March, Frankfurt)
• Annual Meeting (18-21 September, Atlanta, GA)
China ISPE Facility Award
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.
Award setting:
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China ISPE Facility Award of the year
Equipment Innovation
Process Innovation
Operation Excellence
Deadline for material submission: 31st Jan 2016 (On the date of received materials)
Please visit http://www.ispe.org.cn or contact 86-21-23123640 for more details.
2015 ISPE China Events Recap
Time flies, Year of 2015 is just around the corner. The accomplishments we achieved in the past one
year are including but not limited to:
• 2015 ISPE China Biologics Development Symposium (Oct 22-23, Lanzhou)
With the sessions of “Innovative Biologics Development”, “Biologics”, “Clinical”, “Vaccine”, the Symposium
attracted 200+ industry experts and regulators. Attendees were really impressed by excellent presentations
e.g. “Overview of biologics rdev and mfg: case on Roche” by Cindy Shen from Roche, “Developing biologics for
patients” by Guoqing Cao from Hengrui, “Biosimilar Development in the United States, A Case Study” by
Howard Yuwen from Genesun Biopharmaceutical, etc. ISPE also hosted pre-conference workshop to discuss
IND filing.
• ISPE China Training (Jul-Nov, Shanghai)
ISPE China office successfully conducted 9 public trainings including Process Validation Lifecycle, Turning QbD
into a Practical Reality, GMP Auditing, Oral Solid Dosage, Quality Risk Management, HVAC etc. benefiting over
200 participants.
“I feel glad to attend ISPE Commissioning and Qualification training, and excited to getting to know the trainer
and some friends from other pharmaceutical companies. The Trainer, Mr. Ma is great. Although I am a
beginner in validation area, can’t catch up with all points Mr. Ma had presented, I still learnt a lot regarding
scientific and risk assessment based C&Q.” --Emma, NNE Pharmaplan
• 2015 ISPE China Annual Spring Conference (Apr 20-21, Beijing)
More than 650 industry professional and regulators attended 2015 ISPE China Annual Spring Conference,
which is with the theme of “Quality-Foundation for Pharmaceutical Industry”. 70+ industry leaders and experts
from Pfizer, Roche, Novartis, Bayer, Merck, Hengrui, Lilly etc. as well as officials from CFDA, US FDA shared
advanced knowledge, best practice and regulatory expectation at content-rich education sessions.
“This is the first time attending ISPE China Conference for me and I learned a lot from it especially the topic:
China Drug GMP Appendix: Computerized System which spoken by Tiewei Zhai, CFDI. Mr Zhai shared the
latest related regulatory policies which is helpful for my work. ISPE offers a platform for us communicating
with regulators and industry professionals and sharing updated knowledge and technology. I wish ISPE offer
more opportunities to us for such wonderful speeches. ” – Ms Hao, Quality department of CSPC
• Offline community of practice (COP) and facility tour (members only)
ISPE organized 12 offline COP event and facility tour in 2015 for members, visiting Tasly, Beijing Tide Pharm,
Sanofi, Pfizer, Tofflon, Bayer etc.
In the next year, ISPE China will strive to benefit you by creating and bringing more value added
activities and services.
Membership Zone
Nov-Dec 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. ISPE members are able to download this gift package at the beginning of
every month on ISPE China Official Website.
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides

EU and US inspectional approach for Data Integrity

High Potent Facility Design
Notice: Don’t miss your membership benefits.
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: +86-21-2312-3640 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.
Good Practice Guide: Comparator Management
The Guide: Comparator Management is the pharmaceutical industry's first-ever resource for comparator
processes. It has been developed to use as a central reference source that establishes strategic and tactical
considerations related to comparator sourcing. It identifies good practices for making sourcing decisions,
including how to set up a good sourcing team. The Guide also discusses good practices for blinding and
releasing a comparator for use. The Guide will also explain the risks involved with ineffective comparator
methods, and provide companies with strategies for avoiding the costs, delays and potential case study
inaccuracies that might result from faulty comparator management.
Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems
The Guide: Ozone Sanitization of Pharmaceutical Water Systems provides important insight into the design
and use of pharmaceutical ozone sanitization systems, and is the first industry Guidance Document to take a
holistic view of these issues. The Guide provides an overview of ozone sanitization systems, including
regulatory considerations and other factors companies should take into account when deciding to use ozone
vs. other sanitization approaches. It discusses specific system requirements, as well as associated advantages
and disadvantages of using ozone as a water sanitization method. The Guide helps companies better
understand what ozone systems are, why they can be a safer, more efficient and more cost-effective way to
sanitize pharmaceutical water, and how they can be incorporated into both new and retrofitted facilities.
For more information about ISPE publications, please visit ISPE official website or contact 021- 2312 3640 /
china@ispe.org.