In this issue:
•
Concurrent Events during 2015 ISPE China Conference
•
One Week Left for Early Bird Registration for Qingdao Training
•
March-April member gift package is available now
•
ISPE China complete the first draft of Good Laboratories Practice Guide
•
Chinese version of ISPE Guideline: Manufacturing Execution Systems-A strategic and
Program Management Approach will be published soon
Events:
Concurrent Events during 2015 ISPE China Conference
• Biologics Workshop (April 19, Afternoon) - Yong Zhou, from NIFDC will talk about Quality Control System
and Quality Evaluation on Biological Drugs. Open to paid delegates of 2015 ISPE China Conference. Only 20
seats and please contact: +86-21-23123640 for registration.
• Facility Tour (April 22) - Paid delegates of 2015 ISPE China Conference have opportunities to gain an
exclusive insight of the plants by visiting the advanced facilities including Tide Pharm, Beijing Yabao, Bayer and
Novartis. View the detailed program
• Development and Future Trend on CMC Evaluation and Compliance Inspection Forum (Internal Meeting,
April 19) – Regulatory attendees from FDA, CFDI, CDE, ChPC and NIFDC, CFDA.
• China Industry Leadership Forum (invitees only, April 20, Afternoon) - Representatives from FDA, CFDA and
key pharmaceutical industry leaders will discuss the industry hot topics in this forum.
Nearly 50 officials from FDA, FDI, Beijing FDA, Tianjin FDA, Jilin FDA etc. will participate in this annual
conference on April 20-21 at The Westin Beijing Financial Street.
Last 1 week left for online Registration and enjoy Group Rate (5 or more than 5 persons in one company)
One Week Left for Early Bird Registration for Qingdao Training (14-15 May, Holiday Inn Qingdao
Parkview)
• Environmental Control and HVAC for Life Science Facilities
The class will explore critical issues at each stage of the product lifecycle, from R&D to Manufacturing, such as:
controlling cross-contamination between products, proper control of storage temperature and humidity,
setting acceptance criteria for HVAC systems and using risk assessment to set environmental criteria.
• Oral Solid Dosage Forms: Understanding the Unit Operations, Process, Equipment and Technology for OSD
Manufacture
The course uses a Process and Production Simulation for Unit Ops, including Mixing, Blending, Drying, Sizing,
Tableting, Encapsulation and Coating to provide participants with a demonstration of current manufacturing
and engineering practices.
• Applying Quality Risk Management (QRM)
The course will explain the QRM process and roadmap, risk management plan development and
implementation etc. to help students improve daily work and level of risk management in the construction,
rebuilding and expansion of the workshop to achieve the new GMP regulations.
• Science and Risk-based Commissioning and Qualification
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.
• Basic Principles of Computerized Systems Compliance Using GAMP® 5, Including Revised Annex 11 and
Part 11 Update
This course will give participants a practical introduction to the 21 CFR Part 11 including its objectives, benefits,
and potential problems as well as regulation and up-to-the-minute information on the status of FDA's current
re-examination of the regulation. It will be followed by a detailed analysis of Part 11 requirements, a discussion
of electronic records and signatures, and key industry issues.
Register now and enjoy early bird before April 17!
Note: We will only choose 2-3 trainings per registration status
ISPE will join the CIPM this May 17-21
ISPE will join the 49th China International Pharmaceutical Machinery Exposition (CIPM) in Qingdao this May
17-21. In May 17 afternoon, ISPE experts will give the presentations of “Manufacturing Execution Systems”,
“Environmental Monitoring for Sterile Plant” and “Facility and Design”. Welcome to join us and exchange the
thoughts and experience with ISPE experts.
Membership Zone
Mar-Apr 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 Apr 30, 2015)

How Type I Error Impacts Quality System Effectiveness
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (7)

ICH Q11 Guideline: Development and Manufacture of Drug Substance – Implementation and
Challenges ICH Q11

The Role of Solid Form in Generic Drug Development
Notice: Don’t miss your membership benefits.
Volunteers Zone
ISPE China complete the first draft of Good Laboratories Practice Guide
Laboratory provides accurate and reliable data for the various aspects in the lifecycle of drugs. As regulators
attach more importance on data integrity inspection, they take laboratory as the main target in GMP
inspection. ISPE experts from regulatory and industry has drafted Good Laboratory Practice Guide, aiming to
offering guidance and advice on the establishment, operation and management of drug laboratory. The initial
version has been completed and under the process for review. 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 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.
Chinese version of ISPE Guideline: Manufacturing Execution Systems-A strategic and Program
Management Approach will be published soon
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 will be published during 2015 ISPE China Annual Spring Conference which is held in Beijing
this April 20-21.
ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
The guide describes how organizations can move from established baseline practice to a more efficient
science- and risk-based framework. It illustrates the application of Quality Risk Management to traditional
commissioning and qualification practices, linking traditional terminology and approaches to the newer
science- and risk-based specification and verification terminology and approaches applied in ICH Q8, Q9, and
Q10, ASTM E2500, and ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and
Equipment.
ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
HVAC systems can be critical systems that affect the ability of a pharmaceutical facility to meet its objective of
providing safe and effective product to the patient. The guide provides designers and the project team with
suggestions to help determine the user requirements and the functional design that define the facility's
objectives. It also provides options to be considered in creating a design that has low lifecycle cost and which is
sustainable.
For more information about ISPE publications, please visit ISPE official website or contact 021- 2312 3640 /
china@ispe.org.