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Never ever a 483?

We can not promise that you will never get a 483
but we know that the GMP MANUAL includes all 
procedures and processes you need to be
GMP compliant.
 
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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

EMEA and FDA work close together

Get an insight on the progress of collaboration between EMEA and FDA. The European Commission published recently the Implementation report 2009 on the "Transatlantic Administrative Simplification Action Plan".

 

The Implementation report describes on 3 pages the progress in the action plan that is interesting for all pharmaceutical manufacturer and covers also cGMP topics like

  • GMP joint inspections between FDA and EMEA
  • collaboration in 3rd country inspections

The report covers also issues that will be connected indirectly to GMPs

  • combating counterfeit medicines
  • risk management formats
  • dedicated facilities for high risk products
  • exchange of information

See detailed information in the document.

Source: Implementation report 2009

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