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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
EMA Draft: Real Time Release Testing
This guideline addresses the requirements for application of Real Time Release Testing (RTR) testing to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline replaces the previous guideline on parametric release and does not introduce new requirements, so the parametric release part on the previous guideline is retained unchanged.
Replacement:
This guideline replaces the Note for Guidance on Parametric Release CPMP/QWP/3015/99
Outcome:
Consultation Period Ends on August 31, 2010. For your comments use the template linked to the Draft Giudeline. Comments should be send to QWP@ema.europa.eu
Link:
EMA/ Draft Guideline