In this issue:












ISPE Pharmaceutical Quality System (ICH Q10) Conference will be held in Beijing on
Nov 19-20
2014 ISPE China Annual Conference – Join us in Shanghai!
2013 ISPE Public Training Series 3 was successfully held in Shanghai
ISPE Membership dues notification 2014
ISPE will organize the visits to drug factories in Shanghai and Beijing this Nov-Dec
Monthly member gift package is available to download
ISPE Member Development Committee Introduction
ISPE Conference Committee Introduction
A Quantitative Study in Cross Contamination
Project Advantages of Practical Quality
FDA issued draft industrial guide- the biological methods validation in September this
year
Guidance for Industry -Safety Considerations for Container Labels and Carton
Labelling Design to Minimize Medication Errors
Events:
ISPE Pharmaceutical Quality System (ICH Q10) Conference will be held in
Beijing on Nov 19-20
This conference will help attendees to learn the principles and implementation details
of ICH Q10 through establishing Pharmaceutical Quality Systems (PQS), as well as
the benefits of establishing and maintaining a state of control to enhance regulatory
compliance.
Conference Highlights:
● Regulatory officials will share the perspectives and insights into pharm quality from
both US and Chinese side;
● 20+ industry giants’ executives (Merck，Pfizer, Bayer, AstraZeneca, Sanofi, Eli
Lilly, Amgen, Hisun) will share the latest case studies and advanced experience;
● 200 + delegates will build a social platform of exchanging experience, information
and knowledge.
Who shall attend: The decision-makers and senior professionals in Quality
Assurance, Quality Risk Management, Supply Chain, Pharmaceutical Development
and CMC, Regulatory Affairs, Six-sigma and Quality by Design, Manufacturing,
Operations and Engineering
For more information about the conference, please visit: http://www.ispeevent.org.cn/2013ISPEICH_Q10/EN/
2014 ISPE China Annual Conference – Join us in Shanghai!
The long-anticipated ISPE China Annual Conference 2014 will be held in Shanghai
on April 21-22, 2014. As the most influential event in China Pharmaceutical industry,
the conference is designed to cover all chain of pharmacy and meet the practical
need of industry professionals. This is the best marketing and business development
opportunity you should never miss!
Brand your company in the top level Pharmaceutical industry event in China!
ISPE China Annual Conference 2013 Recap:
• 60+ Presidents, VPs, CEOs from leading pharm companies brought the latest
knowledge, information and practical experience.
• Senior regulatory officials from CFDA, US FDA and MHRA shared their insights
into the policy trends
• 5 tracks, 20 + hot topics, cover the entire drug life cycle
• 500 participants, 70% come from manufacturers and 54% are senior managements
For some information about 2013 ISPE China Conference, please visit:
http://www.ispe-event.org.cn/2013ISPEChinaConference/EN/
2013 ISPE Public Training Series 3 was successfully held in Shanghai
Nearly hundred professionals attended the course “OSD”,”C&Q-Science and RiskBased” and “Auditing for GMP”. ISPE selected the hottest topics and case studies in
pharmaceutical industry and invited the prestigious experts to be the instructors. The
students were deeply engaged into the content and discussion, and had a fantastic
experience in instructors’ knowledge, practices and views.
From the attendee:
“I have participated Risk-Based C&Q and systematically and learned about the
application of risk management in the field of C&Q. The instructor helps us to have
an in-depth understanding about the content by illustrating practical cases. I hope
ISPE could develop more similar series of training courses focusing on a specific
topic and field so we can learn the knowledge pertinently.”-- Mr Zhang Shanghai
Johnson&Johnson Pharmaceuticals, Ltd.
For more information please visit http://www.ispe-event.org.cn/ISPEchinatraining/en/
ISPE Member Zone:
ISPE Membership dues notification 2014
In an effort to ensure the Society was accessible to professionals all over the world,
ISPE has significantly subsidized the dues of Members in emerging economy
nations for many years. This has resulted in membership growth in many of those
countries. Unfortunately, the growth ultimately increases the required subsidies.
Effective January 1st, 2014 for all new memberships —Tier 2 Emerging Economy
(e.g.: China) dues are increasing to RMB1190/$175 per year. For renewals, the
increase goes into effect since October 14th 2013.
Besides, for Industrial memberships including Taiwan and Hong Kong members,
dues remain RMB1830/$269 per year (Renewal rate is RMB1560/$229 when
received by membership expiration date).
Thank you for your continued participation as an ISPE Member!
If any question, please contact us. Tel ： +86 21-5108-1512 Email: ispe@china.org
ISPE will organize the visits to drug factories in Shanghai and Beijing this NovDec
To further enrich our membership service, ISPE Membership Development
Committee (MDC) will organize the visits to Boehringer-Ingelheim’s new drug factory
in Shanghai on Nov 22. As a free event to ISPE members, it is a good opportunity to
experience the advanced pharmaceutical factories’ facilities and management.
Please see the agenda below:
Time
Action
13:30
All the visitors meet at the gate of factory
13:30-13:40
Welcome from BI
13:40-15:30
Visit BI factory
15:30-16:15
Q&A
16:15-16:30
End up, group photo
We will also have a facility tour to Bayer Beijing this December. Please pay attention
to ISPE Sina Weibo and WeChat (ISPEChina) to receive the latest information.
If you have any question, please contact us Tel: 86-21-51081512
ispe@china.org
Email:
Monthly member gift package is available to download
ISPE members will receive a free gift including technical and career-focused
webinars, featured selections from ISPE's knowledge base, and other valuable tools
and resources every month.
October member gift (These will be available to you through 30 November2013)
Gift 1: Pharmaceutical Engineering Preview: "Cloud Computing in a GxP
Environment: The Promise, the Reality and the Path to Clarity"
This article explores the “promises” made for cloud computing versus the “reality” of
its use in a regulated environment by examining delivery models available and the
risks to which the industry may be exposed.
Gift 2: Process Validation Presentation: "Business Benefits of Using a Lifecycle
Approach – ROI Model"
This presentation, from the recently concluded 2nd Annual Process Validation
Conference, examines the business benefits of using a lifecycle approach.
Notice: Don’t forget to make the most use of your membership benefits.
ISPE Committees and Activities:
ISPE Member Development Committee Introduction
ISPE membership Development Committee (MDC) is one of subordinate
professional committees of ISPE. It aims at promoting ISPE brand awareness and
influence in the greater China region, actively accelerating the member recruitment
and development, organizing and coordinating various kinds of membership
activities. It also makes great efforts to develop members’ benefits through good
service and bring global pharmaceutical knowledge resources to them.
ISPE Conference Committee Introduction
The Conference Committee's main job is providing a communication platform for the
pharmaceutical enterprises, management organizations, academia to share
knowledge for people in the industry. They can ask questions and solve the problem.
It organizes to hold ISPE annual conference every year, in cooperation with other
committees, providing the pharmaceutical industry with the opportunity to discuss hot
topics.
For more information about ISPE committees, please visit:
https://www.ispe.org/china/board%20and%20committee
ISPE Technical Resources:
A Quantitative Study in Cross Contamination
In 2005, it was clear that regulators around the world were considering adopting
segregation and dedication for all “compound of concern,” such as genotoxic,
mutagenic, carcinogenic, hormones, sensitizers, and beta lactams. The impact to
industry would be incalculable. The reason for this move was the perception that that
cross contamination was rampant.
This article is based on data acquired during an evaluation of the quantifiable risk of
cross contamination in an Oral Solid Dosage (OSD) facility. This article is intended to
provide some quantitative data to an area in which perception and not reality is the
norm. There is really no published data on cross contamination. Read more
Project Advantages of Practical Quality
For many pharmaceutical companies, the science- and risk-based approach is still
new and not straightforward to implement. Although it is at the core of the FDA
cGMP for the 21st Century initiative as well as the joint USA/Europe/Japan effort of
ICH Q8, 9, and 10, many companies are struggling with how to get the principles to
work in practice. Several recent guides support the risk management practices, such
as ISPE’s new Risk-MaPP Baseline Guide, ICH’s Q9 on Quality Risk Management,
ISPE’s GAMP5 the still under development ISPE Baseline Guide: Science and Riskbased Approach for the Delivery of Facilities, Systems, and Equipment, and PDAs
technical report NO.44 Quality Risk Management for Aseptic Products just to
mention some.
Rightly applied, the project advantages of using risk management principles really
support some clear business advantages. Experience from a number of project
indicate that once the pharmaceutical company’s users understand the concepts and
start working in cross-technical and cross-organizational teams together with riskmanagement experts, the learning curve is not difficult to climb.
This article presents four case studies illustrating a wide range of applications for
risk-based approaches in pharmaceutical engineering projects. Read more
For more technical articles, please visit http://www.ispe.org.cn/china/english-version
Latest Regulatory News:
FDA issued draft industrial guide- the biological methods validation in
September this year
This guidance provides general recommendations for bioanalytical method validation.
The recommendations can be modified depending on the specific type of analytical
method used. Read more
Guidance for Industry -Safety Considerations for Container Labels and Carton
Labeling Design to Minimize Medication Errors
The purpose of this guidance is to help prescription drug and biologic product
manufacturers minimize medication errors2 associated with their products. This
guidance focuses on safety aspects of the container label3 and carton labelling
design, and provides a set of principles and recommendations for ensuring that
critical elements of a product’s container labels and carton labelling are designed to
promote safe dispensing, administration, and use of the product. Read more