In this issue:
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3 Days left for early bird of 2015 ISPE China Training
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2015 ISPE China Annual Spring Conference was successfully held
•
2015 ISPE-CCFDIE China Conference-Register now
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May-June member gift package is available now
•
ISPE COP Activity in Shanghai this June
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ISPE China establishes Data Integrity Column
•
Chinese version of ISPE Guideline: Manufacturing Execution Systems-A strategic and
Program Management Approach is published now
Events:
2015 ISPE China Training in Shanghai (20-23 Jul, Shanghai Jiangong Jinjiang Hotel)
Courses at a glance:
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Practical Implementation of Process Validation Lifecycle Approach new!
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Turning QbD into a Practical Reality new!
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Environmental Control and HVAC for Life Science Facilities
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Oral Solid Dosage Forms
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Applying Quality Risk Management (QRM)
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Science and Risk-based Commissioning and Qualification
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Practical Application of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A
Risk-based Approach to Compliant GxP Computerized System
Register now and enjoy early bird before 19, June!
Note: Course will open according to the number of registrants
2015 ISPE-CCFDIE China Conference (Nov 14-16, Shanghai)
Topics at a glance:
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Keynote: Policy and Regulations
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CFDI Session
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Technology transfer and process validation

Data integrity
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The future of factories and industrial 4.0
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Technology Forum of modern Chinese medicine production

GMP regulations and quality
For more information about the conference, please visit: http://ispe.china-pharm.net/en/index.html
Contact person: Mr. Zhu, TEL: 86-10-82212866-6018
2015 ISPE China Annual Spring Conference was successfully held
ISPE China Annual Spring Conference 2015 was successfully held in The Westin Beijing Financial
Street this April 20-21. With the theme of “Quality: Foundation for Pharmaceutical Industry”, this
conference set 5 individual tracks including “Regulatory, Quality and Compliance”, “Facility and
Engineering”, “Drug Product and Manufacturing Process”, “Biological Drug Development and
Manufacturing” and “Clinical Supplies”. Approximately 700 industry leaders, regulators and pharm
professionals attended the pre-conference workshop on Apr 19th and educational sessions on Apr
20-21.
Conference recap
Membership Zone
May-June 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

How Type I Error Impacts Quality System Effectiveness
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (8)

Introduction to Rx-360

PAT and QbD – Building a Comprehensive Program for Quality Management
Notice: Don’t miss your membership benefits.
ISPE COP (June 30, Shanghai) - Member free.
Date: June 30, 1 pm-4 pm
Venue: Tofflon, No.139, Dushi Road, Shanghai
Agenda:
13:10-14:30：Visit pharmaceutical machinery manufacturing workshop
14:45-15:30：Engineering practice about freeze-dried workshop
15:30-16:00：Q&A
Please email China@ispe.org with your name, company, ISPE member ID and mobile No. Please also
indicate “Shanghai COP June 30” in the email subject. If you have any questions please contact Helen Jiang
(021-2312 3640)
Volunteers Zone
ISPE China establishes Data Integrity Column
“Data Integrity" has become a worldwide hot topic at present. MHRA announced the update GMP
Data Integrity Definitions and Guidance for Industry this March. FDA and WHO also have a plan to
release related guidelines this year.
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 will release related articles and case studies, expecting to
communicate with you and get feedback from industry experts.
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 Patrice: 021-2312-3523 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.
Chinese version of ISPE Guideline: Manufacturing Execution Systems-A strategic and Program
Management Approach is published now
The Guide uses a complete lifecycle approach to the development and use of MES for regulated
manufacturing as a collection or domain of manufacturing related functions that integrates business
and process controls, information flow, and human interaction to facilitate the operation of an
organization. It collects and integrates information and knowledge from many disciplines and
sources into a single comprehensive guideline.
The Chinese version is published now and please contact 86-21-2312 3640/ china@ispe.org for more
information.
ISPE Good Practice Guide: Good Engineering Practice
This edition covers the complete lifecycle of engineering from concept to retirement. The Guide:

Aims to promote a common understanding of the concept and principles of GEP defines and
explains the term “Good Engineering Practice”
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Describes the fundamental elements existing in pharmaceutical and related industries
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Identifies practices, demonstrating how GEP concepts may be applied in the pharmaceutical
industry considering the entire range of pharmaceutical engineering activity

Identifies key attributes of GEP, including how GEP relates and interfaces with GxP
ISPE Good Practice Guide: Maintenance
This guide provides practical solutions and tools for ensuring quality and compliance of maintenance
operations in a regulated industry. Covering current and established practices, this guide helps
achieve technical and regulatory accuracy and cost-effective compliance in a new or an existing
maintenance program for effective strategy and efficiency. Offering maximum flexibility, this guide
clearly helps define roles and responsibilities across cross-functional areas and recommends a
systematic approach aimed at continuous improvement of maintenance operations. The Guide is
focused on maintenance in cGMP areas and provides a practical and consistent interpretation of the
necessary elements of a pharmaceutical maintenance program. The Guide seeks to enable
widespread adaptation and encourage innovation.
For more information about ISPE publications, please visit ISPE official website or contact 021- 2312
3640 / china@ispe.org.