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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

EU GMP Part II comes in operation

Revised part II of EU GMP Guideline "Basic Requirements for Active Substances used as Starting Materials" will come into operation by July 31, 2010.

 

The principles of Quality Risk Management in line with the ICH Q9 guideline on Quality Risk Management have become incorporated. A new section on Quality Risk Management is introduced as section 2.19.

Outcome:

Part II of EU GMP Guideline is available online.

Link:

EC/ EU GMP Guideline Part II

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