In this issue:
•
Enjoy early bird for ISPE China Biologics Symposium in Lanzhou
•
Jul-Aug member gift package is available now
•
Cast Your Vote in ISPE International Board Election
•
COP offline event was successfully launched this July
•
ISPE China Data Integrity Roadmap
•
ISPE Publications Recommendation
Events:
Enjoy early bird for ISPE China Biologics Symposium in Lanzhou (22-24 Oct, 2015)
Agenda at a glance:
Oct 22 Afternoon (Thursday):

Specially designed interactive forum devoted to discussion of biosimilar and innovative
drugs regulatory issues with senior CFDA officers and industrial leaders
Oct 23 (Friday):




Innovative Biologics Development
Biologics
Clinical
Vaccine
Oct 24 (Saturday):
 Facility tour
Register now and enjoy early bird before 18, Sep!
2015 ISPE China Training was successfully held
ISPE China office successfully conducted 7 public trainings including Process Validation, Oral Solid
Dosage, Quality Risk Management, HVAC, Quality by Design, Commissioning and Qualification,
GAMP 5 in Shanghai, 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 Annual Meeting (8-11 November, Philadelphia, Pennsylvania USA)
Choose from Six Dynamic Education Tracks: Facilities and Equipment, Product Development and
Production Systems, End-to-End Supply Chain Management, Regulatory Compliance and Quality
Systems, Information Systems and Innovation Forum 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.
Enjoy facility tour during the meeting (Nov 11):

Merck, Gardasil Vaccine Production Facility

Morphotek, Sustainable Facility of the Year

AstraZeneca, New Formulation Suite
View more detailed information
Membership Zone
Jul-Aug 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.
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (9)

Issues on HAVC System

Containment Valve Technology-Finding a way through the maze
Notice: Don’t miss your membership benefits.
Cast Your Vote in ISPE International Board Election
With your continuous trust and support, ISPE has enjoyed the healthy growth. Please accept our
deep gratitude.
Now it’s time to elect the 2016 ISPE International Board of Directors! Please use the personal URL
(members only) sending to your mailbox to access your ballot, review the nomination materials, and
cast your precious vote until 11:59 PM Eastern Daylight Time, Wednesday, 9 September 2015.
Congratulations to Mars Ho, one of 2015-2016 ISPE China Board of Directors, is on the final list of
potential candidates running for the position of ISPE international board of directors, the only
candidate in the Asia-pacific region.
Note that the balloting URL is personal to you. It can be used for voting only once, and it cannot be
used by anyone else.
View the candidates’ biographies
ISPE Website Upgrade Notice
As ISPE website has been upgraded, please kindly go to http://www.ispe.org to change your login
password. The new system requires 7 characters for password, you can log in with the original 6
characters password and then reset it to 7 characters instead.
We also suggest you clear all cookies and bookmarks so when you logged in it brings you to the new
portions of the website instead of the old ones.
Sorry for the inconvenience and should you have any question, please contact ISPE China office via
china@ispe.org.
COP offline event was successfully launched this July
10+ ISPE members visited Hangzhou Minsheng Pharmaceutical and Sanofi this July and acquires a lot
from the practical learning.
“Minsheng Pharma (approved by FDA) and Sanofi (established by the standard of Europe) show the
GMP best practices among domestic pharmaceuticals. Thank you for the arrangement from ISPE and
I learned a lot from the pharma’s high quality equipment, lab design, process etc. I also appreciate
for the opportunity to communicate with other ISPE members. ”- Shanghai Johnson & Johnson
For more offline events, please follow ISPE China Website and WeChat (ISPEChina).
Volunteers Zone
ISPE Data Integrity Roadmap
ISPE (China) Regulatory and Compliance Committee sets up the task force and brings together the
regulators and industry professionals, aiming at discussing the strategy and specific solutions of Data
Integrity implementation with the interpretation and study of regulations and industry good
practices sharing.
The task force released the roadmap to the public recently including Data Integrity definition,
application scope, problems, solutions etc.
Read more about the roadmap
Please follow ISPE WeChat (ISPEChina) if you have any question or comments about Data Integrity.
For the updates about the guide, please visit ISPE China Website or Wechat (ISPEChina).
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 Helen: 021-2312-3640 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.
ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical
Equipment (Second Edition)
The Guide provides technical guidance and consistent methodologies for evaluating the particulate
containment performance (particulate emissions) of pharmaceutical equipment and systems.
This Guide aims to define current good practices, providing information to allow organizations to
benchmark their practices and improve on them. Specifically, the Guide provides a methodology to
derive data associated with handling of pharmaceutical ingredients that is useful in the assessment
of potential risks.
ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and
Equipment
The Guide provides direction to industry on the implementation of a science- and risk-based
approach for demonstrating that pharmaceutical and biopharmaceutical facilities, systems,
equipment, and associated automation are fit for intended use and comply with regulatory
requirements.
The Guide will be of interest to those following the latest industry and regulatory initiatives,
including:

product and process understanding

science- and risk-based approach

application of Quality by Design concepts
For more information about ISPE Guidance documents, please visit ISPE official website or contact
021- 2312 3640 / china@ispe.org.