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We can not promise that you will never get a 483
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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.

Brochure of PDA Parenterals Conference 2010, October 26-28

 

News about GMP/cGMP

2010-04-27

On April 15-16, 2010, more than 140 participants from around 40 states, international organisations and institutions from around the world met in Basel (Switzerland) to discuss the practical implementation of the MEDICRIME Convention.

 
2010-04-26

On April 19, 2010, the European Commission informed, that they will oblige all EU countries to use the European Databank For Medical Devices (EUDAMED) starting on May 2011.

 
2010-04-23

On April 20, 2010 EMA published new information on Heparin Monographs according to the European Pharmacopoeia.

 
2010-04-22

FDAs Task Force concering the Transparency Initiative is collecting information on how to improve FDA's transparency to regulated industry. They held three listening sesions with members of regulated industry during January 2010.

 
2010-04-20
 
2010-04-19

On April 1, 2010 European Pharmacopoeia Commission published information concerning a survey to possible changes regarding Water for Injection.

Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). Renewed discussions have taken place at the end of 2009 amongst regulators in Europe on the suitability of using Reverse Osmosis (RO) to produce WFI. Concerns from regulators regarding the use of RO for the production of WFI had previously been expressed in a reflection paper issued by the Joint CHMP/CVMP Quality Working Party in early 2008.

 
2010-04-16

EFPIA (European Federation of Pharmaceutical Industry and Associations) published the results of their product verification system pilot project on April 12, 2010. The pilot successfully demonstrated a product verification system at the point of drug-dispense of a swedish pharmacy chain. The system is based on a 2-D data matrix code.

 
2010-04-15

On April 7, 2010 CDERs Division of Drug Information (DDI) published a Drug Information Update concerning the changes to the Heparin Sodium USP Monograph.

 
 
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