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Over recent years, Glatt has gradually extended its qualification and validation activities. Our experience can prove invaluable in your risk assessment, when drawing up your validation master plan, and for all other validation-related activities. 

 

We offer a complete facility qualification service.
From the DQ, IQ, OQ through to the PQ phase.
Partial qualification is also possible on request.

 

Risk assessment and validation master plan
If required we can assist you with process validation.

  Restrospectively too.
We will naturally be pleased to validate your existing facilities.
 

Documentation of implemented installations.
Taking into account EC-Guide, GAMP 4, 21 CFR Part II...


 



▶ We offer a complete facility qualification service

Glatt defines qualification as the in-project documentation of relevant quality activities, i.e. documentation firmly anchored in the project itself. Our success has shown us to be right. With its professional and practically-oriented approach, Glatt turns qualification into a target-oriented process rather than a "never-ending story". We work in line with the principles of GMP. The Glatt control system "MegaView", for instance, was developed on the basis of the GAMP4 life cycle. And it goes without saying that Glatt control systems comply with the requirements of 21 CFR part 11.
 

Glatt offers a variety of different qualification packages for different requirements. You decide which resources you wish to invest in qualification or validation, and the degree to which you require our support



























 

Belt speed measurement at a packaging line

Press force measurement at a tablet press

Glatt calibration technician at work
Glatt calibration technician at work
 

Belt speed measurement

Press force measurement

Calibration technician

 



 

 
Our calibrations are performed using measuring devices checked annually for their accuracy



Process principles

 

 

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