The IPEC Federation and Pharmaceutical Quality Group have jointly released the IPEC PQG Good Manufacturing Practice Guide (5th edition, 2022) for pharmaceutical excipients, which is now publicly available worldwide.IPEC China has completed the Chinese translation and officially launched it for members to download!

The new version of the guidelines continues the basic principles of GMP, incorporates the latest concepts, aligns with ISO 9001:2015 standards, and adds GMP interpretation and implementation examples. The guidelines are divided into two parts:

• Part 1 covers the core content of Good Manufacturing Practice for Medicinal Excipients

• Part 2 comes with practical instructions and common examples, without additional requirements

The Chinese translation cannot be separated from the selfless dedication of IPEC China member volunteers. We would like to thank the following volunteers and their employers for their support (in no particular order):

Gaoshan (Yiruian)
Xu Xiaofeng (Kalekang)
Yang Lan (Kalekang)
Li Chunhong (Suzhou Capsule)
Wang Yu (Merck)
Zhang Xia (Ashland)
Zhang Bei (DuPont)
Tian Qin (Merck)

*Copyright © The copyright of the Chinese translation of this guide is owned by the IPEC Alliance

Go to>Home>Resource Download>IPEC Guide, log in to your member account to download Part 1&Part 2 of the IPEC-PQG Good Manufacturing Practice Guide for Medicinal Excipients (5th edition, 2022).

For more information, please contact IPEC China Secretariat via email info@ipec-china.org .