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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

Focus on GMP Training

On January 14, 2010 FDA published a Warning Letter, concerning amongst others a lack of cGMP violations in training affairs.  As you can see there, training-affairs are an important GMP aspect and there will be serious consequences when ignoring them.

 

Outcome:
  • Describe properly the specifc type of training that will be provided to your staff!
  • Define how the effectiveness of the training will be evaluated!
  • In case of re-training progammes (e.g. in consequence of GMP violations): specify how retraining will prevent recurrence of violations!
  • Write down a trainig plan that gives at least information on: staff member, qualification, training subjects, training frequency!
  • Check your training plan minimum once a year and define further measures!
  • Document each training measure and the corresponding evaluation!
  • Don't forget to include external staff and contract workers!
Source:

Warning Letter Sunrise Pharmaceutical

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