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Re: Instrumentation on Validation


Hello Denise:

Thank you for your answer. I think that the information that you mention is
very important ( model and serial numbers, .... ) but I have a daught: is
it no mandatory when a test instrument is used during the Operational
Qualification make one calibration at the beginning and another at the end
of the OQ?. 

Thanks in advance,

Kenia.

Eng. Kenia Vázquez Montero
Validation Department 
CIGB

Evalproc@ta.cigb.edu.cu

----------
From: PharmSciTech <PharmTech@pharmweb1.man.ac.uk>
To: pharmtech@pharmweb1.man.ac.uk
Subject: RE: Instrumentation on Validation
Date: Monday, March 30, 1998 2:51 PM

 Kenia,
 
  We document calibration information for all test (reference)
instruments used during execution. This includes unique identification
numbers, model number, serial number, last calibration date, calibration
due date and calibration file location.

  Denise R. Connelly
  dconnelly@genzyme.com
 
 
> ----------
>From:  PharmSciTech
>Sent:  Thursday, March 26, 1998 5:07 PM
>To:  pharmtech@ade5.pa.man.ac.uk
>Subject:  Instrumentation on Validation
>
>
>Hello to all of the Forum
>
>During the Operational Qualification of our process equipment in the point
>related with the instrumentation we check some aspects concerned with the
>calibration of the instruments on-line and others related with the
process.
>
>We have understood that it is necessary also include this for the
>"external" instruments that we use in validation tests for example:
>Thermocouples for the Heat Distribution Test.
>
>Which aspects from these last must be present on the Validation Report or
>Validation File?
>
>Thanks in advance,
>
>Kenia.
>
>Eng. Kenia Vázquez Montero
>Validation Department 
>CIGB
>
>Evalproc@ta.cigb.edu.cu
>
>
>
>
>
>
>
>

                                                                           
                                                                           
             
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