Gordon Song: New challenge for facility

点击数:21 发布时间:2018-08-10
Gordon Song, Sr. Consultant, Shanghai GQS Pharmaceutical Technology Co.,Ltd.
Gordon Song: New challenge for facility

15 years working experiences in pharmaceutical industry;

over 6 years working experiences in validation & GMP consult;

Clean room CQ expert;

With enough engineering projects validation management experiences;

Be familiar with pharmaceutical C&Q.

Published several professional technical articles about facility, validation, QMS, etc.

Serviced for Zoetis, Jecho, Lilly, Apptec Bio (Shanghai), AZ, Roche, Sotio, Tiantan Bio, Shanghai Pharma, Apeloa, etc.

EU GMP Annex 1 Updating : New challenge for facility

Facility and clean room related key words: Do we really understand them ? For example:

Aseptic Manufacturing Area = Aseptic Processing Facility=Aseptic Processing Room?

Critical Surfaces means? How about Critical areas? How about Aseptically area?

Grade A Air Supply(Local Protection):How to define the environment monitoring criteria of GAAS

CNC:New definition,EMPQ new challenge?

Recovery time: how to test?

Root cause discussion.

Core principles of sterile product manufacturing summarize and elaboration.