Nov-Dec, 2011
In this section:
Members of ILF participant ISPE spring conference in April
ISPE-CCPIC China Conference 2011 successfully held in Shanghai
China Delegation participated in 2012 ISPE Annual Meeting
ISPE attends industry exhibitions
ISPE Online Discussion Forum goes live now!
Two Chinese version ISPE Technical Guides published
ISPE published some new technical guides
Free CPIP training webinar
ISPE Student Facility Design Competition starts
ISPE China Student and Young Professional Committee
ISPE Sponsorship Invitation-Your best ad opportunity
Members of ILF participant ISPE spring conference in April
April 16-17, 2012, ISPE conference will be held in Beijing. Looking at the industry from a global view,
the conference will discuss about current issues and future trends of the pharmacy. Members of
International Leadership Forum (ILF), regulatory agency officers from US, Japan, EU and PIC/S will
participate in this event and highlight as one of the most global networking events.
About ILF: International Leadership Forum (ILF) is one of the most influential pharmaceutical
organizations in the world. All members are high-level leaders in pharmaceutical companies, such as
Pfizer, Sanofi, GSK, Eli Lillly, Johnson & Johnson, Novartis, Bayer, BMS, AstraZeneca, Abbott,
Boehringer-Ingelheim, Novo Nordisk, ILF hold 2 meetings each year, first half year is in Europe, next
half year is in US.
April 15, 2012, ILF will come to Asia and hold one meeting in Beijing, China. Following topics will be
discussed: Next generation processes, equipment and facilities (Plant of Future –POF- concepts),
Biotechnology, Supply Chain Management, Enterprise Risk Management, Sustainability, Professional
Development.
ISPE-CCPIC China Conference 2011 successfully held in Shanghai
On 28th of Oct 2011, the ISPE-CCPIE China Conference 2011 was grandly held in Shanghai. More
than 430 delegates participated in this conference.
Zhang Aiping, the Director of Certification Cmmittee for Drugs of SFDA; Bryan Wright, European
Regulatory Affairs Advisor; Milian Smid, WHO officer of Quality Assurance and Safety of Medicines
Unit; and government officials and experts from Chinese and American drug administration bodies,
leaders of domestic and foreign pharmaceutical companies are invited to speak at the conference.
During the 4-day conference, the “OSD” session led by Jack Chu, P.E.Manager of Merck and Wu Jun,
visiting professor of SDFA Training Center; the “Quality System” session led by Bob Tribe, the Owner
of Bob Tribe Consulting, and the “Sterile” session led by Rob Walker, Director of Rob Walker
Consultancy drew great interests of delegates.
Meanwhile, China Pharmaceutical Leadership Forum highlighted the Conference with industry
leaders‟ hot discussion on new trend and implementation of as part of the Conference to mainly new
China GMP.
ISPE new book launching ceremony held on the second day releases two Chinese version of ISPE
technical guideline books-Baseline Guide Volume 2: OSD” (2nd version) and “Baseline Guide Volume
3: Sterile Manufacturing Facilities (2nd version) . Some delegates ordered the book on the spot. In
addition, a job posting board displayed at the conference attracted a lot of delegates to stay.
An Award Ceremony has been arranged at the banquet aiming to express appreciation to ISPE
committee members. Mars Ho, Chairman of ISPE China presented the Thanks Certificate to
committee members.
Testimonial from one of conference delegates:
“This is my first time to attend ISPE conference. I„ve participated in ISPE conference in US, India and
Singapore. The reason why I went for China Conference is that I realized that pharmaceutical industry
in China has developed very fast and many new projects are emerged. I expect to know more
information about developments and changes in China market. I am really impressed by the speakers;
they gave very good speeches. With the speeches combining domestic with foreign expertise, I
benefit a lot. I am looking forward to attending another conference in 2012.”
John Lam, QA Manager , Beijing Hanlin Hangyu Technological Development Co.Ltd.
China Delegation participated in 2012 ISPE Annual Meeting
ISPE„s 2011 Annual Meeting was successfully held in Grapevine, Texas, US. More than 1400
professionals attended this grand meeting, such as senior-level managers from renowned companies,
professors from universities, officers from governmental branches, etc. In addition to the keynote
sessions and tracks, ISPE also d announced awards such as “Member of the Year “Committee of the
Year”, ISPE‟s Affiliate of the Year”. View detailed awarding information
There are 18 Chinese delegates participating in this event. Among them, Hua Zhang from Shanghai
FDA and Chun Chang from NNE Pharmaplan delivered speeches. China delegation also visited
Alcon Facility in Texas. Wei Wang from the Sichuan University, the winner of ISPE China Poster
Competition also attended the meeting.
International Leadership Forum (ILF) was held at the same time. Mr. Zhaoguang Yan and Mr.
Kecheng Zang from SFDA, Ms. Hua Zhang from Shanghai FDA participated in this high level forum.
The next ISPE annual meeting will be held on 11~14, November, 2012 in San Francisco, USA.click
here to know more information.
ISPE attends industry exhibitions
In Oct - Nov, 2011, the most popular and influential industry exhibition –API & CIPM were held in
Nanjing and Qingdao.
Three ISPE committee members spoke at the exhibition. They are Michael Lee, Vice President of
BIOMAB Pharmaceuticals; Gao Juan, Chief Science Consultant of Shanghai Pharma Group; Peter
Ma, Validation Manager of Austar. They gave speech regarding Pharmaceutical Equipment Planning
and new GMP, More than one hundreds delegates took part in the forum.
ISPE Online Discussion Forum goes live now!
ISPE Online Discussion Forum, a Chinese version pharmaceutical BBS has launched now! Eight
sessions kick off the forum including “Critical Utilities, Biotech, PQLI, C&Q, API, Sterile, OSD, GAMP.
By visiting this online forum, not only can you download ISPE technical articles free of charge, but
also you can communicate with like-minded professionals. Meanwhile, you can post your questions
and issues of day to day work and let your peers online help you out! Also, this BBS will assist you to
expand your social circle.
Online discussion forum: http://blog.ispe.org/forums/
Two Chinese version ISPE Technical Guides published
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Chinese version of “Baseline Guide Volume 2: Oral Solid Dosage Forms” (2 version) and “Baseline
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Guide Volume 3: Sterile Manufacturing Facilities” (2 version) is published and you can buy them
now! The membership price for each technical guide is 350 Yuan
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OSD and Sterile Manufacturing Facilities (2 version) are the most popular technical guides among
the industry professionals. OSD baseline provides a good technical guideline for China
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pharmaceutical manufacturers to reach the international level. Sterile Manufacturing Facilities (2
version), offers practical answers to the complex, dynamic challenges facing facility designers today.
Meanwhile, English e-version Sterile Manufacturing Facilities (2nd version) also has been launched
and the paper version will be published in the end of 2011.
To order the Chinese version “OSD” and “Sterile Manufacturing Facilities”, please contact
china@ispe.org
Reminder: Pricing of each Chinese version GAMP®5 will be changed as RMB 350 Yuan from Jan 01,
2012.
ISPE published some new technical guides
ISPE recently published some new technical guides, including ISPE Good Practice Guide: “Interactive
Response Technology”, “Project Management for the Pharmaceutical Industry”, and Baseline: Water
and Stream Systems. The latest version “Publication Catalogue” has been updated for your
downloading. click here to download.
Recommendation: Baseline Guide: Water and Steam Systems (Second Edition)
The Water and Steam Systems (Second Edition) is the only comprehensive guidance of its kind and
aims to assist with the design, construction, operation, and maintenance of new water and steam
systems that meet current Good Manufacturing Practices (cGMPs) and comply with existing
regulations and related guidance.
New chapters covering microbiological considerations, such as biofilm formation, use of sanitizers,
sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit
operations and finished water have been added.
Free CPIP training webinar
The Certified Pharmaceutical Industry Professional™ (CPIP™) credential is for industry professionals
around the world working in and supporting product development through manufacturing. CPIP has
high reputation among pharmaceutical industry all over the world. Click here to know more
To assist with Chinese pharmaceutical professionals to know better about CPIP credential, ISPE will
organize a complimentary webinar to potential Chinese candidates. 10 participants are limited.
Through this online brief, ISPE expects potential candidates in China can get to more detailed
information about this credential, raise any questions they may have to the trainer. If you are
interested in this training, please send email to china@ispe.org for registration.
ISPE Student Facility Design Competition starts
After ISPE Wall Paper Competition was successfully held, another event organized by ISPE “the
Student Facility Design Competition” is on. Till now, 51 teams from 13 universities have applied for
participating in the competition.
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Prior to December 5 . , 51 teams will submit their works online. Then they will start the competition in
different regions on December 20 - 21th Dec, the final competition will be held in Sichuan University.
ISPE China Student and Young Professional Committee
In this issue, we would like to introduce Student and Young professional Committee of ISPE China.
There are 8 members in this committee and their main responsibilities areis to organize students who
majored in pharmaceutics to visit facility and provide them with internship opportunity, develop
student chapters, hold student competition and face-face membership events or online forums.
During the past year, Student and Young professional Committee have engaged in the Student
Poster Competition organization, COPs networking events, ISPE online forums. Later, the committee
will continue to work with ISPE China to organize more events, such as Student Facility Competition
ISPE Sponsorship Invitation-Your best ad opportunity
2012 ISPE Sponsorship plan starts now! In 2012, companies are eligible to post advertisement via
ISPE website, informer, training, conference, etc. It is the best platform to display your products and
services and enhance brand awareness.
In 2011, to circulate the latest ISPE technology and knowledge, ISPE held 1 Chinese conference and
10 training courses; more than one thousand delegated are participated. Meanwhile, readers of ISPE
website and e-Newsletter have reached to 30,000.
If you have any intention on sponsorship of ISPE, feel free to give a call to: 010-52061082