In this issue:
•
ISPE 2015 Upcoming Events
•
2014 ISPE China Events Recap
•
Nov-Dec member gift package is available now
•
ISPE Volunteer Recruitment
•
ISPE Publications Recommendation
Events:
ISPE 2015 Upcoming Events
2015 ISPE China Annual Spring Conference (Apr 20-21, Beijing)
Theme: Quality- Foundation for Pharmaceutical Industry
Keynote Speech:
Lawrence Yu, Deputy Director, OPQ/CDER/FDA
Dinesh Thakur, Executive Chairman of Medassure
Breakout Tracks:

Regulatory, Quality and GMP

Facility and Engineering

Chemical Drug Product and Manufacturing Process

Biological Drug Product Development and Manufacturing

Clinical Supplies
Register now and enjoy early bird! ISPE Member: RMB 2700 More Conference information
2015 Public Training
• 14-15 May, Qingdao: HVAC / Applying Quality Risk Management/GAMP 5 etc.
• July-August, Shanghai: Process Validation Lifecycle / GMP Auditing/Oral Solid Dosage etc.
Click here for course description
2015 Workshop (Nov, TBC)
Global Events:
• ISPE/FDA Quality Conference (1-3 June, Washington D.C)
• PV Conference: Practical Application of the Lifecycle Approach (7-8 October, Washington, D.C.)
• Annual Meeting (8-11 November, Philadelphia)
2014 ISPE China Events Recap
Time flies, Year of 2014 is just around the corner. The accomplishments we achieved in the past one
year are including but not limited to:
• 2014 ISPE China Biologics Development Symposium (Nov 30-Dec 2, Zhuhai)
With the sessions of “Biologics Development and Manufacturing”, “Analytical, Formulation and Quality”,
“Clinical and Regulatory”, the Symposium attracted 260 industry experts and regulators. Attendees were really
impressed by excellent presentations e.g. “Quality Research and Thoughts on Antibody Biosimilar” by
Mr.Junzhi Wang from NIFDC, “Process Optimization Strategies for Product Quality Control” by Jimmy Li from
Wuxi Apptec, “Biosimilar Guidelines: Case Studies” by Helen Hartman from Pfizer, etc. ISPE also hosted preconference workshop to discuss Downstream and Upstream as well as Biosimilar related issues.
• ISPE China Training (Jul-Nov, Shanghai)
ISPE China office successfully conducted 7 public trainings including GMP Auditing, Oral Solid Dosage, Quality
Risk Management, HVAC etc. and Pharm Manufacturing Facility Design Workshop in Shanghai, benefiting over
200 participants.
“I learned a lot from the training course -Quality Risk Management which is organized by ISPE China. The
instructor answered our question about the problems encountered in operation with its rich fund of
knowledge and shared his own experience which benefit me a lot. We shared working practice with each
other in group and it’s a good platform for networking and communication.” - Mr Chen | Austar
• 2014 ISPE China Annual Spring Conference (Apr 21-22, Shanghai)
More than 550 industry professional and regulators attended 2014 ISPE China Annual Spring Conference,
which is with the theme of “Integration of World Knowledge for Inauguration of Excellent Quality”. 70+
industry leaders and experts from Pfizer, Novartis, Bayer, Merck, Hengrui, Amgen, Hisun, GSK etc. as well as
officials from CFDA, US FDA, PIC/S shared advanced knowledge, best practice and regulatory expectation at
content-rich education sessions.
“I’m really impressed by 2014 ISPE China Annual Spring Conference, especially by the two topics of CAPA and
Stability Study. Shawn Wang and Jiangong Niu proposed solutions for specific problems through SOPs, and
shared practice experience and industry trends. I got some inspiration from their presentation which provides
reference for my daily work.” --- Kerry Yu, Quality Department of Porton Fine Chemicals Co Ltd
• Offline community of practice (COP) and facility tour (members only)
ISPE organized 10 offline COP event and facility tour in 2014 for members, visiting Tasly, Beijing Tide Pharm,
WuXi AppTec, Suzhou Biobay,GE, Genor, Livzon 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. 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 Dec 31, 2014)

How Type I Error Impacts Quality System Effectiveness
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (6)
（ These will be available to you by Jan 7, 2015 )

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 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.
GAMP Good Practice Guide: Electronic Data Archiving (EDA)
This Guide provides a rational and scaleable approach to electronic data archiving through the development of
an archiving strategy. The implementation of such a strategy should assist organizations to achieve and
maintain regulatory compliance, and to more effectively manage electronic records over the long term.
GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and
Signatures (ER&S)
This Guide provides new comprehensive guidance on meeting current regulatory expectations for compliant
electronic records and signatures, which includes the need for record integrity, security, and availability
throughout the required retention period. This is achieved by well-documented, validated systems, and the
application of appropriate operational controls.
For more information about ISPE publications, please visit ISPE official website or contact 021- 2312 3640 /
china@ispe.org.