In this issue:
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10 days left for ISPE Biologics Development Symposium
•
Enjoy early bird for 2015 ISPE China Training
•
2015 ISPE Annual Meeting (8-11 November, Philadelphia, Pennsylvania USA)
•
Notice: ISPE Membership Password Changed
•
ISPE Publications Recommendation
Events:
2015 ISPE Biologics Development Symposium-Register Now
Date: Oct 22-23, 2015
Venue: Lanzhou, China
Find the latest speakers list and program agenda on symposium website.
You’ll hear about the latest information of biosimilar and innovative drugs regulatory issues from
regulatory officials and clinical trial case studies and Vaccine in China etc.
Speakers at a glance:
Junzhi Wang | Deputy Director-General of NIFDC
Xiaodong Wang | Academician of NAS
Howard Yuwen| Co-founder of Genesun Biopharmaceutical, Inc
David Chang | VP/Site Head of Roche Pharma Tech Ops Shanghai
Guoqing Cao | Deputy General Manager of Hengrui
Don’t miss the opportunity to showcase your products and services at this influential event!
Download the Sponsorship plan
Enjoy Early Bird Registration for Shanghai Training (24-27 Nov, East China Normal University)
• Basic Principles of Computerized Systems Compliance Using GAMP® 5, Including Revised Annex
11 and Part 11 Update (Fundamental)
This two-day fundamental course introduces participants to regulatory requirements for
computerized systems in the pharmaceutical industry and explores tried, tested, and internationally
recognized methods of meeting those requirements.
• GMP Auditing (Fundamental)
This course will introduce the basic knowledge of the audit, the critical competencies needed to be a
conscientious auditor, the essential process steps of an audit. It also explains how to prepare the
audits, how to effectively evaluate audit and report findings and the audit skills.
• Science and Risk-based Commissioning and Qualification (Intermediate)
This course will explain and apply the science and risk-based approach to verification of systems,
equipment and facilities in accordance with the ICH documents Q8, Q9, and Q10 and ASTM E-2500.
Topics covered include the principles and activities that constitute an efficient and acceptable
approach to demonstrating facility and equipment fitness for use as required by major global
regulatory authorities etc.
• Analysis of Chinese Medicine Extraction Process Control and Manufacturing Quality Key Check
Points Workshop
The workshop will explain the details according to the construction and production process of
traditional Chinese medicine extraction: including extraction module, module extraction unit
complex concentration, refining, drying module, extraction automatic control module and MES
module.
Register now and enjoy early bird before October 23!
ISPE will join the CIPM this Oct 28-31
ISPE will join the 50th China International Pharmaceutical Machinery Exposition (CIPM) in Wuhan
this Oct 28-31. In Oct 28 afternoon, ISPE experts will give the presentations of “Oral Solid Dosage”,
“Project Review by Stage” and “Industrial Standard 4.0”. Welcome to join us and exchange the
thoughts and experience with ISPE experts. Booth: A1-30-3
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
ISPE Website Upgrade Notice
As ISPE website has been upgraded, membership ID remain the same, whilst your membership
password has been changed to 7 characters,

If your membership ID is seven numbers, your password is the same with your ID;

If your membership ID is six numbers, please add a lowercase letter “c” before your ID (e.g.
ID: 123456, PW: c123456);

If your membership ID is five numbers, please add lowercase letter “cc” before your ID (e.g.
ID: 12345, PW: cc12345).
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.
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 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, please contact 021- 2312 3640 / china@ispe.org.