【中文】

IPEC 欧洲药用辅料新闻简报7/8月

2010-12-15
 

IPEC e-newsletter - Excipients Insight July/August 2010 - 9/1/2010

 

Inside this issue

•  Word of the Chair
•  Members’ corner
•  IPEC Europe hosts falsified medicines webinar
•  Certification project reaches unified document stage
•  News from the committees
•  IPEC Europe Calendar
•  EDQM updates heparin monographs and standards
•  Ph. Eur. Commission names vice chairs
•  CHMP concept paper on modified release product quality
•  Guidelines on residual solvents adopted by EMA
•  Conference considers future direction of EMA
•  EMA and FDA seeking joint inspection candidates
•  Senate bill aims to improve manufacturing quality standards
•  FDA publishes Q&A on GMP for holding, distribution
•  New Chair for IPEC China
•  Download IPEC Guides
•  Events calendar
     

Word of the Chair

 

Dear Members,

Warm greetings to you all and welcome to this month’s double issue ofExcipients Insight, picking up all the excipient-related news which emerged over the summer break. I hope you all enjoyed some time away on vacation and have returned on fine form for the last third of the year.

The pages of this edition contain information on some of IPEC Europe’s most important projects, including Excipact, monograph harmonization, updating the SQAS ESAD scheme and the excipient master file, as well as a new initiative on excipient quality risk management. We will revisit these topics in greater depth in the coming months.

Our newsletter continues to evolve, so do please let either myself or the secretariat know your comments and suggestions to improve the content and/or layout.

On behalf of Beam Suffolk, chair of the IPEC Europe Board,

Phil Taylor

Editor

 

 

 

 

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