GAMP (Good Automated Manufacturing Practice) simplified please.

R

Rashmi001

#1
I've recently been asked by my senior management to provide a very simple overview of GAMP for them, and our IT folk, to better understand what is required for compliance purposes.

I have read through the PICS documents and validation of computerised systems and I am not sure quite where to start. We are a hospital blood bank to which the Blood Safety and Quality Regulations apply.

Any help with identifying the key points for GAMP would be much appreciated.

Many thanks!
 
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G

George Weiss

#2
Re: GAMP simplified please.

The guys on top always like pictures, so give them a presentation. @
http://www.ispe.org/galleries/sanfrancisco-files/GAMP%20Presentation%20to%20ISPE.pdf
.
The guys on top always like pictures, so give them a presentation. @
http://www.ispe.org/galleries/sanfrancisco-files/GAMP%20Presentation%20to%20ISPE.pdf
.
follow it up with some more details @
http://www.vialis.ch/fileadmin/files/imgs/pdf/Newsletter/q1-09/08MJ-Martin.pdf
.
Technical reviews are a good refined presentation source @
http://www.pmeasuring.com/wrap/filesApp/tp26/file_1/pharma_tp26GAMP4.pdf
.
which all ties back to GMP overview @
http://www.chem.agilent.com/Library/eseminars/Public/Regulations%20and%20Quality%20Standards%20in%20Laboratories.pdf
All this is likely understood, and a repeat, but here it is anyway…………………
.
:agree1:
 
Last edited by a moderator:

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
We are talking about this, correct?

ISPE GAMP: Guide for Validation of Automated Systems
GAMP 4, Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems
International Society for Pharmaceutical Engineering / 2001 / 320 pages
 
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