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procedures and processes you need to be
GMP compliant.
Newsletter registration
PDA Parenterals Conference
From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.
This outstanding event will cover the very important topics:
- Future of Parenterals
- Packaging and Impact on Quality
- Manufacturing Flexibility and Control
- Innovative Plants
- Monitoring Technologies
- Medical and Application Devices
- Regulatory Trends
Don´t miss this interesting conference in Berlin, Germany.
News about GMP/cGMP
ICH Japan Symposium 2009
The meeting entitled "ICH Japan Symposium 2009" is the second regional ICH public meeting held in Japan which took place at the Tower Hall Funabori in Tokyo on June 12, 2009, the following day of the ICH Yokohama Meeting (June 6 - 11, 2009).
The Symposium aimed to provide an opportunity to update to the public on the progress made during the ICH meeting in Yokohama and on the status of the various ICH guidelines under development. It also aimed to provide an opportunity for participants and the ICH experts/rapporteurs to have a Q&A on a face-to-face basis on all the topics discussed at the Yokohama Meeting.
At page 65-80 (pdf page 76-91) the quality topics and Q&As
- Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
- Q11Development and Manufacturing of Drug Substances
- Q-IWG Quality Implementation Working Group
are covered.
Source: ICH Press Release